a sysmex group company hemostasis product catalogue · hemoclot™ a range of clotting assays...

HYPHEN BioMed155 rue d’Eragny, 95000 Neuville-sur-Oise, France • Tel: +33 (0)1.34.40.65.10 • Web : www.hyphen-biomed.com

A Sysmex Group Company

Hemostasis Product Catalogue

Experience the innovation!

Edition 2019-2021

© Sakurra / Shutterstock.com

1 www.hyphen-biomed.com

Company Overview

Company’s Presentation:HYPHEN BioMed, a Sysmex Group company, is a highly specialized company for in-vitro hemostasis and thrombosis diagnostic reagents, expanding rapidly. Its major activity concerns designing, developing, manufacturing and marketing research and diagnostic solutions for the exploration of Thrombosis, Hemostasis and Auto-Immunity. These reagents are available worldwide, through an extensive network of specialized distributors, or directly from the company (when no local distributor is available). A major company’s speci�city is to focus only on biological reagents, which is the expertise core of HYPHEN BioMed. These products can be applied to the various available automated platforms. The company then ambitions o�ering to laboratory managers the reagents of choice needed for their laboratory applications, and brings full support for setting up laboratory method in each speci�c context.

HYPHEN BioMed laboratories are equipped with all the major available automated coagulation analyzers, and also highly performing analytical instruments and manufacturing equipment. The facility is optimized for the company’s speci�c requirements, committed to o�er specialized research and routine diagnostic tools to the scienti�c and medical community. This high technology environment is continuously evolving in order to adapt to new needs and expectations, for manufacturing all innovative reagents originated from our research.

The company develops and produces the major raw materials required for its very speci�c activity. They are speci�cally designed and prepared for matching with the reagents and

assays’ requirements. The latest laboratory equipments for cell culture, production of recombinant proteins, engineering and puri�cation of proteins from plasma or biological extracts, and developing multi-technology laboratory methods are available, and updated on regular basis. Manufacturing equipment includes various lyophilizers, with a full capacity for very large lots (> 100,000 vials /lot), and fully automated �lling, capping and labelling lines (with a capacity of 20,000 vials/hour).

HYPHEN BioMed has become especially a major partner for pharmaceutical industries, particularly for those involved in developing and marketing anticoagulant, antithrombotic and coagulation factor substitutive drugs, or for drug discovery. As an expert company, HYPHEN BioMed provides innovative and added-value solutions to hospital laboratories (e.g., DOACs, HIT, Hemophilia), research institutes and pharmaceutical industry (including customized reagents and techniques). Our unique o�er for high quality products and services is promoted and adapted to each laboratory expectation by the company’s network of specialized distributors, who are �rst scienti�c and technical advisors and partners, listening to all speci�c needs.

Find your local distributor and partner on our web site.

Quality System :One of the company’s major objectives is to achieve excellence in the quality of products, services and support by adhering to international quality standards. HYPHEN BioMed is certi�ed ISO 13485:2016 and MDSAP (Medical Device Single Audit Program), the new International Standard for Medical Devices (TÜV Rheinland).

The basic objectives and commitments of each HYPHEN BioMed employee are dedicated to deliver to customers full satisfaction through the quality of products and services.

HYPHEN BioMed develops and markets diagnostic reagents, many of which are CE marked and 510(k) cleared. The o�er concerns clotting, chromogenic and immunological assays for measuring all anticoagulant drugs, blood extracts and recombinant substitutive therapies, as well as all which is needed for thrombosis and hemostasis laboratory applications.

www.hyphen-biomed.com 2

Company Overview

AsiaEurope

Oceania

North America

South America

Africa

Products and Applications:We are proud to contribute to healthcare progresses thanks to today’s technological innovations and our mind is totally focused to meet this challenge.

Within this way, HYPHEN BioMed proposes a complete and continuously growing line of reagents including: puri�ed proteins and enzymes, monoclonal and polyclonal antibodies (on demand), various immunoconjugates, chromogenic, clotting and immunological kits for research or diagnosis. This line allows exploring blood coagulation, thrombosis and �brinolysis, as well as Thrombosis associated Auto-Immune disorders.

Our reagents are not only acknowledged worldwide for their quality and innovation, but also as useful tools for the pharmaceutical research and drug discovery. Especially, they allow testing the e�cacy and safety of new anticoagulant and antithrombotic drugs under current development. When needed, technologies are then available as companion diagnostics for these new drugs.

All methods proposed are designed for multi-platform applications. Speci�c instrument protocols are developed, and made available to all customers for facilitating and bringing value to their laboratory work.

Distribution Network:Our produts car available today almost worldwide through the extensive distribution network.

Find your local representative at:w w w . h y p h e n - b i o m e d . c o m

More about CompanyTo know more about HYPHEN BioMed,visit our website: www.hyphen-biomed.comor contact us at:

Address: 155 rue d’Eragny 95000 Neuville-sur-Oise, FranceTel: +33 (0)1 34 40 65 10Fax: +33 (0)1 34 48 72 36

For Technical Support:e-mail: [email protected]

Other questions/general info:e-mail: [email protected]

Company’s Philosophy:The vision and mission of HYPHEN BioMed’ s company is reminded in the company’s name. “Hyphen” is a word originated from the ancient Greek, used to symbolize “links” “relationships” in literature and scienti�c schemes and drawings.It represents the “bow” ( ) used for establishing these links. It is the ancestor of the English word “hyphen”.

HYPHEN BioMed development is based on a network of know-how and expertises. It has been accomplished through the association of complementary knowledges, competences, and technological specialties.

This original approach was to �rst create and value “links”, o�ering new research and diagnostic tools to the scienti�c and medical community. Now the company is a major partner in hemostasis and thrombosis.

HYPHEN BioMed has a continuous growth, thanks to its high commitment to Innovation. The company is located in the Technological Park of Neuville University (95000, France).


Catalogue Overview

Product Line Concept

BIOPHEN™ Innovative technology of chromogenic assays as well as calibrators and controls (traceable to international standards) for IVD but also research and pharmaceutical activity.

HEMOCLOT™ A range of clotting assays designed with highly puri�ed coagulation factors for IVD and research use as well as pharmaceutical activity.

ZYMUTEST™ Complete line of highly sensitive, accurate speci�c Enzyme Immunoassays (ELISA) which remains the reference method for the exploration of thrombotic diseases, �brinolysis, autoimmunity or drug induced complications such as HIT.

Please note that this catalogue contains information on products which is targeted to a wide range of audiences and could contain product details or information otherwise not accessible or valid in your country. For more information, please contact our local representatives in your country. https://www.hyphen-biomed.com/distributors

HYPHEN BioMed can also develop customized products. If you need a reagent, calibrators and controls for your project, please contact us - we may be able to help you.e-mail: [email protected], Tel: +33 (0)1 34 40 65 10

Customized Products

Definition

NEW: Products released recently and already available on the market.

On-demand: Products manufactured on demand. Please contact HYPHEN BioMed or your local representatives for minimum quantity and lead time.

Available soon: Products planned to be launched soon. Please contact HYPHEN BioMed for availability.

IVD: In-Vitro Diagnostic use.

CE: CE marked product for IVD use.

LRT: Liquid Reagent Technology. For ready-to-use reagents.

Abbreviation

DOAC: Direct Oral Anticoagulant

HIT: Heparin Induced Thrombocytopenia

vWD: von Willebrand Disease

RUO: For Research Use Only.

LIAPHEN™ A range of turbidimetric latex immunoassays for quantitative determination of di�erent molecules on citrated human plasma or puri�ed �uid.

ZYMUPHEN™ Proprietary bio-immunoassays, highly speci�c, for testing rare protein activities in coagulation and �brinolysis (such as tPA, PAI-1, TF, TAFI, EVs...).


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Table of Contents

Section 1. Global Assays ....................................................................................... 5

Section 2: Factor Assays........................................................................................ 7

Section 3: Anticoagulant Monitoring .........................................................11

Section 4: Thrombophilia...................................................................................15

Section 5. Platelet Function Assays ..............................................................19

Section 6. Hemophilia, vWD and other bleeding disorders .............21

Section 7. Fibrinolysis..........................................................................................23

Section 8. Calibrators & Controls ...................................................................25

Section 9. Auxiliary reagents ...........................................................................29

Section 10. Research ............................................................................................31

INDEX

by Product Name ................................................................................................35

by Catalogue Number.......................................................................................37


Section 1:

Complete line of routine assays for hemostasis testing

Section 1: Global Assays


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Section 1:Section 1: Global Assays

NEW

Product Name Description Reference Presentation

CK581 12 x 4 mL

CK582 12 x 8 mL

CK583 12 x 18 mL


CK511K 6 x 1 mL

CK512K 6 x 2.5 mL

CK515K 8 x 5 mL

CK515L 12 x 5 mL

CK521K 6 x 1 mL

CK522K 6 x 2.5 mL


FIBRIPHEN™ LRT CE-IVDReagent for clotting method for fibrinogen, Claussquantitative Assay. Liquid reagent, ready to use. CK585K 6 x 5 mL

CK571K 6 x 1 mLCK572K 6 x 2 mLCK575K 8 x 5 mL

LIAPHEN™ Fibrinogen CE-IVDTurbidimetric latex immunoassay for the quantitativedetermination of Fibrinogen Antigen. 120102 4 x 5 mL

ZYMUTEST™ Fibrinogen RUOELISA Method for the quantitative determination ofFibrinogen Antigen. RK024A 96 tests


HEMOCLOT™ Thrombin Time LRT CE-IVDReagent for clotting method for the determination of thrombin time in human ci trated plasma .Liquid reagent, ready to use.

CK012K 6 x 5 mL

CK011K 6 x 2 mL

CK011L 6 x 8 mL

CK001K 6 x 2 mL

CK001L 6 x 8 mL

Prothrombin Time

Activated Partial Thromboplastin Time

Fibrinogen

Thrombin Time

FIBRIPHEN™ CE-IVDReagent for clotting method for fibrinogen, Claussquantitative Assay.

CEPHEN™ LS Liquid APTT Lupus sensitive

CE-IVDReagent for clotting method for the determination ofActivated Partial Thromboplastin Time, sens itive toci rculating Lupus Anticoagulant.

Reagent for clotting method for the determination of Activated Partial Thromboplastin Time .

CEPHEN™ Liquid APTT

CE-IVD

Calcium Thromboplastin Reagent for thedetermination of prothrombin time (PT). It i sdes igned wi th human recombinant TF, wi th an ISIclose to 1.00.

CE-IVD(h)PT-phen™

RUO

CE-IVD

HEMOCLOT™ Thrombin (human)

Reagent for the determination of Thrombin Time(purified thrombin mostly of α−form).

HEMOCLOT™ Thrombin Time (T.T.)

Reagent for clotting method for the determination ofthrombin time in human ci trated plasma .


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Section 1:Section 2: FactorAssays

Measurement of plasma factors and some of their activated forms involved in coagulation and thrombosis using clotting, chromogenic or immunological methods.

Assay Portfolio for Factors and other Hemostatic Proteins

Prothrombin

Factor V

Factor VII

Factor VIIa

Factor VII-X

Factor VIII:C

Factor IX

Factor IXa

Factor X

Factor XI

Factor XIa

Factor XII

Factor XIII

Immuno Depleted Plasma

(p. 8)

DP010A / DP010K

DP020A / DP020K

DP030A / DP030K

- -DP040A / DP040K

DP050A / DP050K

-DP060A / DP060K

DP070A / DP070K

-DP080A / DP080K

DP200A / DP200K

Clotting Method(p. 8 & 9)

- CK071K CK081K CK092KCK051K / CK051L

- - - - - - - -

Chromogenic(p. 8 & 9)

- - 221304 221312 -221402 / 221406

221801 / 221802 / 221806

221812 221705 - 220412 - -

Specific Control Set(p. 26)

- - - 224901 - - - 224601 - - 224801 - -

ELISA(p. 8 & 9)

- RK009A RK036A - - - RK032A - RK033A - - -RK034A

on-demand

* see section "Research" for other plasma deficient


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Section 1:Section 2: Factor Assays

RUO

Immunodepleted Plasma for Clotting Assays


DP010A 1 x 1 mL

DP010K 6 x 1 mL

DP020A 1 x 1 mL

DP020K 6 x 1 mL

DP030A 1 x 1 mL

DP030K 6 x 1 mL

DP040A 1 x 1 mL

DP040K 6 x 1 mL

DP050A 1 x 1 mL

DP050K 6 x 1 mL

DP060A 1 x 1 mL

DP060K 6 x 1 mL

DP070A 1 x 1 mL

DP070K 6 x 1 mL

DP080A 1 x 1 mL

DP080K 6 x 1 mL

See on page 34 for deficient plasma for a research use only

Clotting, Chromogenic and Immunological Assays

Factor VProduct Name Description Reference Presentation

HEMOCLOT™ Factor V Reagent CE-IVDClotting method for quantitative determination of FV,requires a ca lcium Thromboplastin. CK071K 6 x 1 mL

ZYMUTEST™ Factor V RUO ELISA method for quantitative determination of FVantigen. RK009A 96 tests

Factor VIIProduct Name Description Reference Presentation

HEMOCLOT™ Factor VII Reagent CE-IVDClotting method for quantitative determination of FVII,requires a ca lcium Thromboplastin. CK081K 6 x 1 mL

BIOPHEN™ VII CE in progress

Chromogenic assay for quantitative determination ofFVII . 221304 R1, R3: 2 x 4 mL ; R2: 2 x 2 mL

R4: 4 x 25 mL

ZYMUTEST™ Factor VII RUOELISA method for quantitative determination of FVIIantigen. RK036A 96 tests

CK051K 6 x 1 mL

CK051L 20 x 1 mL

Factor VIIaProduct Name Description Reference Presentation

HEMOCLOT™ Factor VIIa CE-IVDClotting method for quantitative determination ofActivated FVII . CK092K R1, R2: 3 x 2 mL; R3: 3 x 20 mL

BIOPHEN™ Factor VIIa RUOChromogenic assay for quantitative determination ofActivated FVII . 221312 R1, R3 : 2 x 4 mL; R2 : 2 x 2 mL;

R4 : 2 x 25 mL

BIOPHEN™ FVIIa Control Set CE-IVD Refer to section 8. Calibrators and Controls (page 26). 224901 C1, C2 : 3 x 1 mL each

HEMOCLOT™ VII-X CE-IVDClotting method for quantitative determination of FVIIand FX, requires a ca lcium Thromboplastin.

Factor IX Deficient Plasma CE-IVD Citrated human plasma deficient in Factor IX

Factor X Deficient Plasma CE-IVD Citrated human plasma deficient in Factor X

Factor XI Deficient Plasma CE-IVD Citrated human plasma deficient in Factor XI

Factor XII Deficient Plasma CE-IVD Citrated human plasma deficient in Factor XII

Factor VII Deficient Plasma CE-IVD Citrated human plasma deficient in Factor VII

Factor VIII:C Deficient Plasma CE-IVD Citrated human plasma deficient in Factor VIII

Clotting assays for the quantitative determination of factors activity in citrated human plasma, requires a calciumThromboplastin (FII, FV, FVII, FX) and cephaline / Calcium (FVIII, FIX, FXI, FXII) reagent.

Prothrombin Deficient Plasma CE-IVD Citrated human plasma deficient in Factor I I

Factor V Deficient Plasma CE-IVD Citrated human plasma deficient in Factor V


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Section 1:Section 2: Factor Assays

NEW

Factor VIII:CProduct Name Description Reference Presentation

221402 R1, R2, R3: 2 x 2.5 mL; R4: 4 x 25 mL

221406 R1, R2, R3: 2 x 6 mL; R4: 4 x 25 mL

Factor IXProduct Name Description Reference Presentation

221801 R1, R2, R3: 2 x 1 mL; R4: 2 x15 mL

221802 R1, R2, R3: 2 x 2.5 mL; R4: 2 x 25 mL

221806 R1, R2, R3: 2 x 6 mL; R4: 4 x 25 mL

ZYMUTEST™ Factor IX RUO ELISA method for quantitative determination of FIXantigen. RK032A 96 tests

Factor IXaProduct Name Description Reference Presentation

BIOPHEN™ Factor IXa (ACT. FIX) RUO Chromogenic assay for quantitative determination ofActivated FIX. 221812 R1, R2, R3: 2 x 2.5 mL

R4: 2 x 25 mL ; Cal: 2 x 1 mL

BIOPHEN™ FIXa Control Set RUO Refer to section 8. Calibrators and Controls (page 26). 224601 C1, C2: 6 x 1 mL each

Factor XProduct Name Description Reference Presentation

CK051K 6 x 1 mL

CK051L 20 x 1 mL

BIOPHEN™ Factor X RUO Chromogenic assay for quantitative determination of FX. 221705 R1, R2: 4 x 2.5 mL ;R3: 4 x 5 mL

ZYMUTEST™ Factor X RUO ELISA method for quantitative determination of FXantigen. RK033A 96 tests

Factor XIaProduct Name Description Reference Presentation

BIOPHEN™ Factor XIa RUO Chromogenic assay for quantitative determination ofActivated FXI . 220412 R1A, R1B, R2, R3: 2 x 3.0 mL

R4: 2 x 25 mL ; Cal: 2 x 2 mL

BIOPHEN™ FXIa Control Set RUO Refer to section 8. Ca l ibrators and Control s (page 26). 224801 C1, C2: 3 x 1 mL each

Factor XIIIProduct Name Description Reference Présentation

BIOPHEN™ Factor XIII CE-IVDChromogenic method for quantitative determination ofFactor XIII activi ty. 227005 R1: 3 x 4 mL ; R2: 3 x 5 mL

ZYMUTEST™ Factor XIII-A RUOELISA method for quantitative determination of FXIII(sub-uni t A).

RK034Aon-demand

96 tests

See on page 32 for hemostasis protein assay for a research use only

HEMOCLOT™ VII-X CE-IVDClotting method for quantitative determination of FVIIand FX, requires a ca lcium Thromboplastin.

BIOPHEN™ Factor IX CE-IVDChromogenic assay for quantitative determination ofFIX.

BIOPHEN™ FVIII:C CE-IVDChromogenic assay for quantitative determination ofFVIII:C.


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Activation, Regulation, Inhibition of Blood Coagulation


Section 1:Section 3: Anticoagulant Monitoring

Complete range of reagents, calibrators and controls (HEMOCLOT™ and BIOPHEN™) for measurement of direct anticoagulants, heparins and their analogues for Diagnostic, Research and Pharmaceutical Industry use (methods adhere to recommendations of the European Pharmacopoeia).

Dedicated Calibrator and Controls

Assay Portfolio for Anticoagulant Treatments

LMWHUFH

Orgaran® and other

Sodium Danaparoïd

Arixtra® and other

Pentasaccharides

Rivaroxaban

Apixaban

Edoxaban

Dabigatran

Argatroban

Bivalirudin

Hirudin

IVD, CE

RUO

Chromogenic assay for direct anti-IIa.

Clotting assay for direct anti-IIa.

Chromogenic assay for direct anti-Xa.

Lyophilized chromogenic assay for anti-Xa.

Liquid chromogenic assay for anti-Xa.

Chromogenic anti-Xa assay by addition ofAntithrombin.

Chromogenic anti-IIa assay followingrecommendations of Pharmacopoeia.

Chromogenic anti-IIa assay

Chromogenic anti-Xa assay followingrecommendations of Pharmacopoeia.

BIOPHEN™ Anti-IIa (2 stages Heparin Assay)

BIOPHEN™ Heparin Anti-IIa (kinetics)

BIOPHEN™ Anti-Xa (2 stages Heparin Assay)

BIOPHEN™ Heparin (AT+)

BIOPHEN™ DTI

HEMOCLOT™ Thrombin

Inhibitors

BIOPHEN™ DiXaI

BIOPHEN™ Heparin

BIOPHEN™ Heparin LRT

Heparins and their Analogues Direct Anti-Xa Direct Anti-IIa

Dedicated Calibrators and Controls

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Reagents for Heparins and their AnaloguesProduct Name Description Reference Presentation

221011 R1, R2: 4 x 7.5 mL

221013 R1, R2: 3 x 3 mL

221015 R1, R2: 4 x 5 mL

221003 R1, R2: 3 x 3 mL

221006 R1, R2: 4 x 6 mL

BIOPHEN™ Heparin (AT+) RUOChromogenic assay for quantitative determination ofanti-Xa activi ty, us ing exogenous AT source . 221007 R1, R2: 2 x 7.5 mL

R3: 2 x 2.5 mL

BIOPHEN™ Anti-Xa (2 Stages Heparin Assay)

RUOTwo stages Anti-Xa chromogenic method for theHeparin activi ty measurement on plasma or purifiedmedium, according to Pharmacopeia .

221005 R1, R2, R3: 2 x 1 mL

BIOPHEN™ Anti-IIa(2 Stages Heparin Assay)

RUOTwo stages chromogenic method for the Heparin anti-I Ia activi ty measurement on plasma or purifiedmedium, according to Pharmacopeia .

220005 R1, R2, R3: 2 x 1 mL

BIOPHEN™ Heparin Anti-IIa (kinetics)

RUO Chromogenic Kinetic assay for quantitativedetermination of anti-I Ia activi ty for purified fluids . 221020 R1:2 x 5 mL

R2, R3: 2 x 10 mL ; R4: 2 x 20 mL

Calibrators and ControlsLow Molecular Weight Heparin (LMWH)


BIOPHEN™ Heparin Calibrator CE-IVD510(k)

Refer to section 8. Calibrators and Controls (page 26). 222001 5 levels , 4 x 1 mL each

223001 C3, C4: 6 x 1 mL each

223801 C3: 12 x 1 mL

224201 C4: 12 x 1 mL

223701 CI, CII : 6 x 1 mL each

224301 CI : 12 x 1 mL

224401 CII : 12 x 1 mL

Unfractionated Heparin (UFH)


BIOPHEN™ UFH Calibrator CE-IVD510(k)

Refer to section 8. Calibrators and Controls (page 26). 222301 5 levels , 4 x 1 mL each

223101 C1, C2: 6 x 1 mL each

224101 C1: 12 x 1 mL

223901 C2: 12 x 1 mL

Orgaran®


BIOPHEN™ Orgaran® Calibrator CE-IVD Refer to section 8. Calibrators and Controls (page 26). 222201 5 levels , 4 x 1 mL each

BIOPHEN™ Orgaran® Control CE-IVD Refer to section 8. Calibrators and Controls (page 26). 223501 2 levels , 6 x 1 mL each

Arixtra®


BIOPHEN™ Arixtra® Calibrator CE-IVD Refer to section 8. Calibrators and Controls (page 26). 222501 4 levels , 3 x 1 mL each

BIOPHEN™ Arixtra® Control Plasma

CE-IVD Refer to section 8. Calibrators and Controls (page 26). 224001 2 levels , 6 x 1 mL each

Human citrated plasma assayed for Fondaparinux (Arixtra®) using anti-Xa Heparin assay.

Refer to section 8. Calibrators and Controls (page 26).



BIOPHEN™ LMWH Control

BIOPHEN™ UFH Control

Human citrated plasma assayed for Sodium Danaparoide (Orgaran®) using anti-Xa Heparin assay.

CE-IVD510(k)

CE-IVD510(k)

Human citrated plasma assayed for UFH using anti-Xa Heparin assay.

BIOPHEN™ LMWH Control Low CE-IVD510(k)

Human citrated plasma assayed for LMWH using anti-Xa Heparin assay.

Chromogenic assay for quantitative determination of anti-Xa activi ty. Lyophi l i zed reagent.

CE-IVD510(k)BIOPHEN™ Heparin

Chromogenic assay for quantitative determination of anti-Xa activi ty. Liquid reagent, ready to use. CE-IVDBIOPHEN™ Heparin LRT


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Reagents for Direct Factor Xa Inhibitors (DiXaIs)Product Name Description Reference Presentation

221011 R1, R2: 4 x 7.5 mL

221013 R1, R2: 3 x 3 mL

221015 R1, R2: 4 x 5 mL

221003 R1, R2: 3 x 3 mL

221006 R1, R2: 4 x 6 mL

BIOPHEN™ DiXaI CE-IVDChromogenic assay for quantitative determinationof anti-Xa activi ty. Specific for DiXaIs . 221030 R1, R2: 3 x 2.5 mL

R3 : 4 x 20 mL

Dilution buffer


AR032A 4 x 20 mL

AR032K 4 x 20 mL

Calibrators and controls for Direct Factor Xa Inhibitors (DiXaIs)Rivaroxaban


BIOPHEN™ Rivaroxaban Calibrator Low CE-IVD Refer to section 8. Calibrators and Controls (page 27). 226001 3 levels , 4 x 1 mL each

BIOPHEN™ Rivaroxaban Control Low CE-IVD Refer to section 8. Calibrators and Controls (page 27). 225101 2 levels , 6 x 1 mL each

BIOPHEN™ Rivaroxaban Calibrator CE-IVD Refer to section 8. Calibrators and Controls (page 27). 222701 3 levels , 4 x 1 mL each

BIOPHEN™ Rivaroxaban Control CE-IVD Refer to section 8. Calibrators and Controls (page 27). 224501 2 levels , 6 x 1 mL each

Apixaban


BIOPHEN™ Apixaban Calibrator Low CE-IVD Refer to section 8. Calibrators and Controls (page 27). 226101 3 levels , 4 x 1 mL each

BIOPHEN™ Apixaban Control Low CE-IVD Refer to section 8. Calibrators and Controls (page 27). 225201 2 levels , 6 x 1 mL each

BIOPHEN™ Apixaban Calibrator CE-IVD Refer to section 8. Calibrators and Controls (page 27). 226201 3 levels , 4 x 1 mL each

BIOPHEN™ Apixaban Control CE-IVD Refer to section 8. Calibrators and Controls (page 27). 225301 2 levels , 6 x 1 mL each

Edoxaban


BIOPHEN™ Edoxaban Calibrator Low CE-IVD Refer to section 8. Calibrators and Controls (page 27). 226401 3 levels , 4 x 1 mL each

BIOPHEN™ Edoxaban Control Low CE-IVD Refer to section 8. Calibrators and Controls (page 27). 225401 2 levels , 6 x 1 mL each

BIOPHEN™ Edoxaban Calibrator CE-IVD Refer to section 8. Calibrators and Controls (page 27). 226501 3 levels , 4 x 1 mL each

BIOPHEN™ Edoxaban Control CE-IVD Refer to section 8. Calibrators and Controls (page 27). 225501 2 levels , 6 x 1 mL each

Reagents for Direct Thrombin Inhibitors (DTIs)Product Name Description Reference Presentation

CK002K R1, R2: 3 x 1 mL

CK002L R1, R2: 3 x 2.5 mL

BIOPHEN™ DTI CE-IVDChromogenic assay for quantitative determinationof DTI activi ty. Specific to DTIs . 220202 R1, R2, R3: 2 x 2.5 mL

Human Plasma assayed for Edoxaban (Lixiana®, or Savaysa®) quantitative measurement using an anti-Xa method

HEMOCLOT™ Thrombin Inhibitors CE-IVDClotting assay for quantitative determination of DTIactivi ty.

BIOPHEN™ Heparin LRT CE-IVDChromogenic assay for quantitative determination of anti-Xa activi ty. Liquid reagent, ready to use.

Human Plasma assayed for Apixaban (Eliquis®) quantitative measurement using an anti-Xa method

Human Plasma assayed for Rivaroxaban (Xarelto®) quantitative measurement using an anti-Xa method

BIOPHEN™ Heparin CE-IVD510(k)

Chromogenic assay for quantitative determinationof anti-Xa activi ty. Lyophi l i zed reagent.

Special dilution buffer reducing heparin Interferences for anti-Xa chromogenic assays

Tris NaCl EDTA buffer, pH 7.85 RUO Buffers for chromogenic assays .NEW


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Calibrators and controls for Direct Thrombin Inhibitors (DTIs)

Dabigatran


BIOPHEN™ Dabigatran Calibrator Low CE-IVD Refer to section 8. Calibrators and Controls (page 27). 222901 3 levels , 4 x 1 mL each

BIOPHEN™ Dabigatran Control Low CE-IVD Refer to section 8. Calibrators and Controls (page 27). 225001 2 levels , 6 x 1 mL each

BIOPHEN™ Dabigatran Plasma Calibrator

CE-IVD Refer to section 8. Calibrators and Controls (page 27). 222801 3 levels , 4 x 1 mL each

BIOPHEN™ Dabigatran Control Plasma CE-IVD Refer to section 8. Calibrators and Controls (page 27). 224701 2 levels , 6 x 1 mL each

Argatroban


Argatroban Plasma Calibrator CE-IVD Refer to section 8. Calibrators and Controls (page 27). SC030K 5 levels , 4 x 1 mL each

Argatroban Control Plasma CE-IVD Refer to section 8. Calibrators and Controls (page 27). SC035K 2 levels , 6 x 1 mL each

Bivalirudin


BIOPHEN™ Bivalirudin Calibrator CE-IVD Refer to section 8. Calibrators and Controls (page 28). 226701 5 levels , 2 x 1 mL each

BIOPHEN™ Bivalirudin Control CE-IVD Refer to section 8. Calibrators and Controls (page 28). 225701 2 levels , 3 x 1 mL each

Hirudin


Plasma Hirudin Standard Low CE-IVD Refer to section 8. Calibrators and Controls (page 28). SC020Kon-demand

2 levels , 3 x 1 mL each

Plasma Hirudin Standard High CE-IVD Refer to section 8. Calibrators and Controls (page 28). SC020Lon-demand


Plasma Hirudin control CE-IVD Refer to section 8. Calibrators and Controls (page 28). SC025Kon-demand


Reagents for the detection of Heparin Induced Thrombocytopenia (HIT)

ScreeningProduct Name Description Reference Presentation

ZYMUTEST™ HIA IgGAM CE-IVD510(k)

ELISA method for detection of heparin dependentantibody IgGAM. RK040D 96 tests

ZYMUTEST™ HIA MonoStrip, IgGAM CE-IVD510(k)

ELISA method for detection of heparin dependentantibody IgGAM, monostrip. RK041D 4 x 8 tests

IsotypingProduct Name Description Reference Presentation

ZYMUTEST™ HIA IgG CE-IVD510(k)

ELISA method for detection of heparin dependentantibody IgG. RK040A 96 tests

ZYMUTEST™ HIA Mono Strip, IgG CE-IVD510(k)

ELISA method for detection of heparin dependentantibody IgG, monostrip. RK041A 4 x 8 tests

ZYMUTEST™ HIA IgA CE-IVDELISA method for detection of heparin dependentantibody IgA.

RK040Con-demand

96 tests

ZYMUTEST™ HIA IgM CE-IVDELISA method for detection of heparin dependentantibody IgM.

RK040Bon-demand

96 tests

ZYMUTEST™ HIA IgG, IgA, IgM CE-IVDELISA method for detection of heparin dependentantibody IgG, IgA or IgM.

RK040Eon-demand

96 tests

Standardised ELISA method optimised for the detection of Heparin-dependent Antibodies in human plasma, serum or any biological fluid, allowing confirmation of HIT/HITT diagnosis or its clinical suspicion.

Human citrated plasma assayed for Argatroban (Arganova®) quantitative measurement using an anti-IIa method

Human citrated plasma assayed for Hirudin quantitative measurement using an anti-IIa method

Human citrated plasma assayed for Bivalirudin quantitative measurement using an anti-IIa method

Human citrated plasma assayed for Dabigatran (Pradaxa®) quantitative measurement using an anti-IIa method

NEW

NEW

15

Section 1:Section 4: Thrombophilia


Measurement of plasma proteins controlling thrombosis andexhibiting antithrombotic properties (PC, PS, AT, etc...).

Regulation of blood coagulationthrough the Protein C/Protein S and AT pathways

ProcoagulantAntithrombotic

VIII

IXa VIIIa

X

PC

Thrombomodulin

Heparin

VIIaTF

VII

Plasmin

Plasminogen

IX

PS

TFPI

Prothrombin

V

Xa Va

Fibrinogen

Thrombin

Fibrin

PS

APC

AT III


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221123 R1, R2: 3 x 3 mL

221127 R1, R2: 4 x 7.5 mL

221102 R1, R2: 2 x 2.5 mL ; R3: 2 x 5 mL

221105 R1, R2: 4 x 5 mL; R3: 4 x 10 mL

BIOPHEN™ AT (Anti-IIa) CE-IVDChromogenic assay for quantitative determination ofAT by Anti-I Ia method. 221122 R1, R2: 2 x 2.5 mL

R3 : 2 x 25 mL

LIAPHEN™ AT CE-IVDTurbidimetric latex immunoassay for the quantitativedetermination of AT Antigen. 120002 R1: 2 x 2 mL, R2: 2 x 10 mL


HEMOCLOT™ Protein C CE-IVDClotting method for quantitative determination ofProtein C activi ty. CK031K R1, R2: 3 x 1 mL

BIOPHEN™ Protein C (LRT) CE-IVDChromogenic assay for quantitative determination ofProtein C activi ty. Liquid reagent, ready to use. 221211 R1 , R2 3 x 3 mL

BIOPHEN™ Protein C CE-IVD510(k)

Chromogenic assay for quantitative determination ofProtein C activi ty. Lyophi l i zed reagent. 221205 R1, R2: 4 x 5 mL

ZYMUTEST™ Protein C CE-IVDELISA method for quantitative determination ofProtein C Antigen. RK027A 96 tests


LIAPHEN™ Free Protein S CE-IVDImmunoturbidimetric assay for quantitativedetermination of Free Protein S Antigen (Free PS:Ag). 120004 R1: 4 x 3 mL, R2: 4 x 4.4 mL

CK041K R1, R2: 3 x 1 mL

CK042K R1, R2: 3 x 2 mL

ZYMUTEST™ Free Protein S (II) CE-IVDELISA method for quantitative determination of FreeProtein S. RK015B 96 tests


HEMOCLOT™ Quanti V-L CE-IVD510(k)

Clotting method for quantitative determination ofactivated Protein C res is tance activi ty. CK065K R1: 3 x 2 mL; R2: 3 x 1 mL

BIOPHEN™ V-L CAL (Undiluted) CE-IVD510(k)

Refer to section 8. Calibrators and Controls (page 28). 222401 3 levels, 3 x 0.5 mL each

BIOPHEN™ Act. PC-r Control Plasma CE-IVD510(k)

Refer to section 8. Calibrators and Controls (page 28). 223405 12 x 0.5 mL

BIOPHEN™ Normal Control Plasma CE-IVD510(k)

Refer to section 8. Calibrators and Controls (page 28). 223201 12 x 1 mL


ZYMUTEST™ Protein Z RUO ELISA ki t for quantitative determination of Protein Z. RK031A 96 tests

Chromogenic assay for quantitative determination ofAT by Anti-Xa (human FXa ) method. Liquid reagent,ready to use.

BIOPHEN™ Antithrombin CE-IVD510(k)

Chromogenic assay for quantitative determination ofAT by Anti-Xa (bovine FXa ) method.

BIOPHEN™ AT anti-(h)-Xa LRT

Protein Z

Activated Protein C resistance

Protein S: Activity and Antigen

Protein C: Activity and Antigen

Antithrombin

CE-IVD

Clotting method for quantitative determination of Protein S activi ty.

CE-IVDHEMOCLOT™ Protein S

NEW

NEW

NEW


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Section 1:Section 4:Thrombophilia

Product Name Description Reference PresentationCK090K 6 x 1 mL

CK094K 12 x 2 mL

HEMOCLOT™ LA-C CE-IVDDRVV reagent wi th high Phosphol ipid content toconfirm the presence of Lupus Anticoagulants . CK091K 6 x 1 mL

LA Control Plasma CE-IVD Refer to section 8. Calibrators and Controls (page 28). SC081K C1, C2 : 6 x 0.5 mL each

LA Control Plasma Weak CE-IVD Refer to section 8. Calibrators and Controls (page 28). SC082K C1 : 6 x 0.5 mL

LA Control Plasma High CE-IVD Refer to section 8. Calibrators and Controls (page 28). SC083K C2 : 6 x 0.5 mL

BIOPHEN™ Normal Control PlasmaCE-IVD510(k)

Refer to section 8. Calibrators and Controls (page 26). 223201 12 x 1 mL

Product Name Description Reference PresentationZYMUTEST™ Anti- β2-Glycoprotein 1, IgG

CE-IVDELISA method for quantitative determination of Anti-β2-Glycoprotein 1, IgG - Isotype . RK014A 96 tests

ZYMUTEST™ Anti-β2-Glycoprotein 1, IgM

CE-IVDELISA method for quantitative determination of Anti-β2-Glycoprotein 1, IgM - Isotype . RK014B 96 tests


ZYMUTEST™ ACA-APA, IgG CE-IVDELISA method for quantitative determination of Anti-cardiol ipin/Anti-Phosphol ipid IgG i sotype .

RK029Aon-demand

96 tests

ZYMUTEST™ ACA-APA, IgM CE-IVDELISA method for quantitative determination of Anti-cardiol ipin/Anti-Phosphol ipid IgM isotype .

RK029Bon-demand

96 tests


ZYMUTEST™ Anti-Annexin V, IgG RUOELISA method, specific for quantitative determinationof Anti-Annexin V, IgG. RK005A 96 tests

ZYMUTEST™ Anti-Annexin V, IgM RUOELISA method, specific for quantitative determinationof Anti-Annexin V, IgM. RK005B 96 tests

ZYMUTEST™ Anti-Protein S, IgG RUOELISA method, specific for quantitative determinationof Anti-Protein S, IgG. RK020A 96 tests

ZYMUTEST™ Anti-Protein S, IgM RUOELISA method, specific for quantitative determinationof Anti-Protein S, IgM. RK020B 96 tests

ZYMUTEST™ Anti-Protein Z, IgG RUOELISA method, specific for quantitative determinationof Anti-Protein Z, IgG. RK025A 96 tests

ZYMUTEST™ Anti-Protein Z, IgM RUOELISA method, specific for quantitative determinationof Anti-Protein Z, IgM. RK025B 96 tests

ZYMUTEST™ Anti-Prothrombin IgG RUOELISA method, specific for quantitative determinationof Anti-Prothrombin, IgG.

RK007Aon-demand

96 tests

ZYMUTEST™ Anti-Prothrombin IgM RUOELISA method, specific for quantitative determinationof Anti-Prothrombin, IgM.

RK007Bon-demand

96 tests

Autoantibodies to Phospholipid Cofactor Proteins

Anti-Cardiolipin / Anti-Phospholipid Antibodies (ACA/APA)

Anti-β2GP1 Auto-antibodies

Lupus Anticoagulant

HEMOCLOT™ LA-S CE-IVDDRVV reagent to screen for the presence of Lupus Anticoagulants .


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ZYMUTEST™ DDimer RUOELISA method for quantitative determination ofDDimers . RK023A 96 tests

ZYMUTEST™ FPA RUOCompetitive ELISA ki t for quantitative determinationof FPA in bentonite adsorbed human plasma . RK016A 96 tests

ZYMUTEST™ CRP RUO ELISA ki t for quantitative determination of CRP. RK010A 96 tests

ZYMUPHEN™ MP-ACTIVITY RUOChromogenic assay for mi croparticles 's procoagulant activi ty in human plasma 521096 2 x 48 tests

ZYMUPHEN™ MP-TF RUOChromogenic assay for quantitative determination ofexposed Ti s sue Factor mi croparticles 's procoagulantactivi ty (MP-TF)

521196 2 x 48 tests

ZYMUTEST™ Tissue Factor (full length)

RUOEnhanced ELISA ki t for quantitative determination ofTi s sue Factor (FL-TF global 1-263) RK035A 96 tests

ZYMUTEST™ Total Tissue Factor RUOEnhanced ELISA ki t for quantitative determination ofTi s sue Factor (Global 1-263 and extracel lular 1-219only).

RK042A 96 tests

Pathological markers

Section 1:Section 5: Platelet Function Assays


Extended range of reagent line for Platelet functional assays including reagents for Platelet Aggregation.

Sect

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5:

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Section 1:Section 5: Platelet Functional Assays

Sysmex CS-5100 Sysmex CS-2100i Sysmex CS-2500


* Example of the results

Platelet activation markerProduct Name Description Reference Presentation

ZYMUTEST™ PF4 RUO ELISA ki t for quantitative determination of PF4. RK006A 96 tests

Plasma PF4 control RUO Qual i ty control plasma for PF4 SC013K 2 levels , 3 x 0.5 mL each

Platelet aggregation reagentsProduct Name Description Reference Presentation

ADP CE-IVD ADP (200 µM) AG001K 3 x 0.5 mL

Epinephrine CE-IVD Epinephrine (1 mM) AG002K 3 x 0.5 mL

Arachidonic Acid CE-IVD Arachidonic Acid (sodiumsa l t- 5 mg/mL (15 mM)) AG003K 3 x 0.5 mL

Ristocetin CE-IVD Ristocetin (7.5 mg per via l ) AG004K 3 x 0.5 mL

Collagen CE-IVD Col lagen (1 mg/mL) AG005K Reagent: 3 x 0.5 mL;Diluent: 3 x 12 mL

AG006A 1 x 5 mL

AG006K 3 x 5 mL

Note: Applications are available on Sysmex CS-series (CS-2000i/CS-2100i/CS-5100)

Platelets for determination of vWF through Ris tocetin Co-Factor Assay.Lyophilized Platelets CE-IVD


Section 1:

Complete line of diagnostic assays for Hemophilia and Other Bleeding Disorders

Section 6: Hemophilia, von Willebrand Disease

and Other Bleeding Disorders


Sect

ion

6:

Ble

edin

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isor

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Section 1:Section 6:

Hemophilia, von Willebrand Diseaseand Other Bleeding Disorders

NEW

Hemophilia AProduct Name Description Reference Presentation

221402 R1, R2, R3: 2 x 2.5 mL; R4: 4 x 25 mL

221406 R1, R2, R3: 2 x 6 mL; R4: 4 x 25 mL

DP040A 1 x 1 mL

DP040K 6 x 1 mL

Auto and Allo-antibodies Anti-Factor VIIIProduct Name Description Reference Presentation

ZYMUTEST™ Anti-VIII Mono Strip IgG

CE-IVDELISA method for quantitative determination of Anti-FVIII IgG. RK039A 32 tests

Hemophilia BProduct Name Description Reference Presentation

221801 R1, R2, R3: 2 x 1 mL; R4: 2 x 15 mL

221802 R1, R2, R3: 2 x 2.5 mL; R4: 2 x 25 mL

221806 R1, R2, R3: 2 x 6 mL; R4: 4 x 25 mL

DP050A 1 x 1 mL

DP050K 6 x 1 mL

ZYMUTEST™ Factor IX RUOELISA method for Factor IX antigen in ci trated humanplasma or other biologica l fluids . RK032A 96 tests

Product Name Description Reference Présentation

LIAPHEN™ vWF:Ag CE-IVD

Immunoturbidimetric assay for in vi tro quantitativedetermination of von Wi l lebrand Factor Antigen (vWF:Ag) on human ci trated plasma . Liquid reagent, ready touse.

120206 R1: 4 x 5 mL; R2: 4 x 6 mL

ZYMUTEST™ vWF CE-IVDELISA method for quantitative determination of vonWi l lebrand Factor (vWF) Antigen. RK030A 96 tests

ZYMUTEST™ vWF:CBA CE-IVDELISA method for quantitative determination ofcol lagen binding activi ty (CBA) of von Wi l lebrandFactor.

RK038A 96 tests

Ristocetin CE-IVD Ristocetin (7.5 mg per via l ) AG004K 3 x 0.5 mL

AG006A 1 x 5 mL

AG006K 3 x 5 mL


HEMOCLOT™ Factor VIIa CE-IVDClotting method for quantitative determination ofActivated FVII . CK092K R1, R2: 3 x 2 mL; R3: 3 x 20 mL

BIOPHEN™ Factor VIIa RUO Chromogenic assay for quantitative determination ofActivated FVII . 221312 R1, R3 : 2 x 4mL; R2 : 2 x 2mL;

R4 : 2 x 25mL

BIOPHEN™ FVIIa Calibrator CE-IVD Refer to section 8. Calibrators and Controls (page 26). 226301 6 x 2 mL

BIOPHEN™ FVIIa Control Set CE-IVD Refer to section 8. Calibrators and Controls (page 26). 224901 C1, C2 : 3 x 1 mL


BIOPHEN™ Factor IXa (ACT. FIX) RUO Chromogenic assay for quantitative determination ofActivated FIX. 221812 R1, R2, R3: 2 x 2.5 mL

R4: 2 x 25 mL ; Cal: 2 x 1 mL

BIOPHEN™ Factor XIa RUO Chromogenic assay for quantitative determination ofActivated FXI . 220412 R1A, R1B, R2, R3: 2 x 3.0 mL

R4: 2 x 25 mL ; Cal: 2 x 2 mL

BIOPHEN™ FIXa Control Set RUO Refer to section 8. Calibrators and Controls (page 26). 224601 C1, C2: 6 x 1 mL each

BIOPHEN™ FXIa Control Set RUO Refer to section 8. Calibrators and Controls (page 26). 224801 C1, C2: 3 x 1 mL each

Others activated factors

Monitoring of by-passing agents

von Willebrand Desease

BIOPHEN™ Factor IX CE-IVDChromogenic assay for quantitative determination of

FIX in human plasma or therapeutic concentrate .

Lyophilized platelets CE-IVDPlatelets for determination of vWF activi ty throughRistocetin Co-Factor assay.

Hemophilia

BIOPHEN™ FVIII:C CE-IVDChromogenic assay for quantitative determination of FVIII:C in human plasma or therapeutic concentrate.

Immunodepleted plasma deficient in FVIII .

Factor IX Deficient Plasma CE-IVD Immunodepleted plasma deficient in Factor IX

Factor VIII:C Deficient Plasma CE-IVD


Complete range of reagents, calibrators and controls for Fibrinolysis exploring

Pro-�brinolytic

Anti-�brinolytic

Fibrinolysis Mechanisms

Section 1: Section 7: Fibrinolysis


Sect

ion

7:

Fibr

inol

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n

Section 1:Section 7: Fibrinolysis

Plasminogen and α2-antiplasmin


BIOPHEN™ Plasminogen (LRT) CE-IVDChromogenic assay for quantitative determination ofPlasminogen activi ty. Liquid reagent, ready to use. 221511 R1, R2: 3 x 3 mL

BIOPHEN™ α2-Antiplasmin (LRT) CE-IVDChromogenic assay for quantitative determination ofα2-antiplasmin. Liquid reagent, ready to use. 220502 R1, R2: 3 x 3 mL

PAI-1 and tPA: Activity and Antigen


ZYMUTEST™ PAI-1 Activity RUOELISA method for quantitative determination of PAI-1activi ty. RK019A 96 tests

ZYMUTEST™ PAI-1 Antigen CE-IVDELISA method for quantitative determination of PAI-1antigen. RK012A 96 tests

ZYMUPHEN™ tPA Activity RUOImmunoenzymatic assay for quantitativedetermination of tPA activi ty.

521296on-demand

96 tests

ZYMUTEST™ tPA Antigen CE-IVDELISA method for quantitative determination of tPAantigen. RK011A 96 tests

TAFI


ZYMUTEST™ (Total) TAFI:Ag RUOELISA method for quantitative determination ofhuman Tota l TAFI Antigen. RK008A 96 tests

ZYMUTEST™ (Activatable) TAFI RUOELISA method for quantitative determination ofhuman TAFI activi table forms . RK037A 96 tests

Controls for reagents for Fibrinolysis Assays.


Plasma PAI-1 control RUO Refer to section 8. Calibrators and Controls (page 28). SC011K 2 levels , 3 x 1 mL each

Plasma U.T.A. control (uPA/tPA/Annexin V)

RUO Refer to section 8. Calibrators and Controls (page 28). SC017K 2 levels , 3 x 1 mL each

25

Section 1:Section 8: Calibrators and Controls

Complete line of calibrators and controls, standardized against WHO International Standards (when available), for the measurement of the various proteins involved in regulation of blood hemostasis and thrombosis as well as for anticoagulant drugs.


Sect

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8:

Cal

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BIOPHEN™ Plasma Calibrator CE-IVD510(k)

Normal Human Plasma for the cal ibration of somecoagulation factors . 222101 12 x 1 mL

BIOPHEN™ Normal Control Plasma CE-IVD510(k)

Normal Control Plasma for coagulation assay qual i tycontrol . 223201 12 x 1 mL

BIOPHEN™ Abnormal Control Plasma CE-IVD510(k)

Abnormal Control Plasma for coagulation assay qual i tycontrol . 223301 12 x 1 mL

EASYPLASMA™ Calibrator CE-IVDRoutine cal ibrator plasmas wi th l imi ted numbers ofparameters . 226601 6 x 1 mL

EASYPLASMA™ Control Set CE-IVDRoutine control plasmas wi th l imi ted numbers ofparameters . 225601 C1, C2: 6 x 1 mL each


BIOPHEN™ FVIIa Calibrator CE-IVD Cal ibrator for Factor VIIa assays . 226301 6 x 2 mL

BIOPHEN™ FVIIa Control Set CE-IVD Factor VIIa qual i ty control set. 224901 C1, C2 : 3 x 1 mL each

BIOPHEN™ FIXa Control Set RUO Factor IXa qual i ty control set. 224601 C1, C2: 6 x 1 mL each

BIOPHEN™ FXIa Control Set RUO Factor XIa qual i ty control set. 224801 C1, C2: 3 x 1 mL each

Low Molecular Weight Heparin (LMWH)Product Name Description Reference Presentation

BIOPHEN™ Heparin Calibrator CE-IVD510(k)

LMWH ca l ibrator plasma set. 222001 5 levels , 4 x 1 mL each

223001 C3, C4: 6 x 1 mL each

223801 C3: 12 x 1 mL

224201 C4: 12 x 1 mL

223701 CI, CII : 6 x 1 mL each

224301 CI : 12 x 1 mL

224401 CII : 12 x 1 mL

Unfractionated Heparin (UFH)Product Name Description Reference Presentation

BIOPHEN™ UFH Calibrator CE-IVD510(k)

UFH ca l ibrator plasma set. 222301 5 levels , 4 x 1 mL each

223101 C1, C2: 6 x 1 mL each

224101 C1: 12 x 1 mL

223901 C2: 12 x 1 mL

Orgaran®Product Name Description Reference Presentation

BIOPHEN™ Orgaran® Calibrator CE-IVD Orgaran® ca l ibrator plasma set. 222201 5 levels , 4 x 1 mL each

BIOPHEN™ Orgaran® Control CE-IVD Orgaran® qual i ty control plasma set. 223501 2 levels , 6 x 1 mL each

Arixtra®Product Name Description Reference Presentation

BIOPHEN™ Arixtra® Calibrator CE-IVD Arixtra® ca l ibrator plasma set. 222501 4 levels , 3 x 1 mL each

BIOPHEN™ Arixtra® Control Plasma CE-IVD Arixtra® qual i ty control plasma set. 224001 2 levels , 6 x 1 mL each

CE-IVD510(k)

UFH qual i ty control plasma set. BIOPHEN™ UFH Control

Multi-Calibrators and Controls

Activated Factor Specific Calibrator and Controls

Heparins and their Analogues

LMWH qual i ty control plasma set.

LMWH qual i ty control plasma set, low range .CE-IVD510(k)BIOPHEN™ LMWH Control Low

CE-IVD510(k)BIOPHEN™ LMWH Control


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RivaroxabanProduct Name Description Reference Presentation

BIOPHEN™ Rivaroxaban Calibrator Low CE-IVD Rivaroxaban ca l ibrator plasma set, low range . 226001 3 levels , 4 x 1 mL each

BIOPHEN™ Rivaroxaban Control Low CE-IVD Rivaroxaban qual i ty control plasma set, low range . 225101 2 levels , 6 x 1 mL each

BIOPHEN™ Rivaroxaban Calibrator CE-IVD Rivaroxaban ca l ibrator plasma set, s tandard range . 222701 3 levels , 4 x 1 mL each

BIOPHEN™ Rivaroxaban Control CE-IVD Rivaroxaban qual i ty control plasma set, s tandard range . 224501 2 levels , 6 x 1 mL each

ApixabanProduct Name Description Reference Presentation

BIOPHEN™ Apixaban Calibrator Low CE-IVD Api xaban ca l ibrator plasma set, low range . 226101 3 levels , 4 x 1 mL each

BIOPHEN™ Apixaban Control Low CE-IVD Api xaban qual i ty control plasma set, low range . 225201 2 levels , 6 x 1 mL each

BIOPHEN™ Apixaban Calibrator CE-IVD Api xaban ca l ibrator plasma set, s tandard range . 226201 3 levels , 4 x 1 mL each

BIOPHEN™ Apixaban Control CE-IVD Api xaban qual i ty control plasma set, s tandard range . 225301 2 levels , 6 x 1 mL each

EdoxabanProduct Name Description Reference Presentation

BIOPHEN™ Edoxaban Calibrator Low CE-IVD Edoxaban ca l ibrator plasma set, low range . 226401 3 levels , 4 x 1 mL each

BIOPHEN™ Edoxaban Control Low CE-IVD Edoxaban qual i ty control plasma set, low range . 225401 2 levels , 6 x 1 mL each

BIOPHEN™ Edoxaban Calibrator CE-IVD Edoxaban ca l ibrator plasma set, s tandard range . 226501 3 levels , 4 x 1 mL each

BIOPHEN™ Edoxaban Control CE-IVD Edoxaban qual i ty control plasma set, s tandard range . 225501 2 levels , 6 x 1 mL each

DabigatranProduct Name Description Reference Presentation

BIOPHEN™ Dabigatran Calibrator Low CE-IVD Dabigatran ca l ibrator plasma set, low range . 222901 3 levels , 4 x 1 mL each

BIOPHEN™ Dabigatran Control Low CE-IVD Dabigatran qual i ty control plasma set, low range . 225001 2 levels , 6 x 1 mL each

BIOPHEN™ Dabigatran Plasma Calibrator

CE-IVD Dabigatran ca l ibrator plasma set, s tandard range . 222801 3 levels , 4 x 1 mL each

BIOPHEN™ Dabigatran Control Plasma CE-IVD Dabigatran qual i ty control plasma set, s tandard range . 224701 2 levels , 6 x 1 mL each

ArgatrobanProduct Name Description Reference Presentation

Argatroban Plasma Calibrator CE-IVD Argatroban ca l ibrator plasma set. SC030K 5 levels , 4 x 1 mL each

Argatroban Control Plasma CE-IVD Argatroban qual i ty control plasma set. SC035K 2 levels , 6 x 1 mL each

Direct Anti-Xa Inhibitors

Direct Thrombin Inhibitors


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BivalirudinProduct Name Description Reference Presentation

BIOPHEN™ Bivalirudin Calibrator CE-IVD Biva l i rudin ca l ibrator plasma set. 226701 5 levels , 2 x 1 mL each

BIOPHEN™ Bivalirudin Control CE-IVD Biva l i rudin qual i ty control plasma set. 225701 2 levels , 3 x 1 mL each

HirudinProduct Name Description Reference Presentation

Plasma Hirudin Standard Low CE-IVD Hirudin ca l ibrator plasma set, low range . SC020Kon-demand


Plasma Hirudin Standard High CE-IVD Hirudin ca l ibrator plasma set, high range . SC020Lon-demand


Plasma Hirudin control CE-IVD Hirudin qual i ty control plasma set. SC025Kon-demand



BIOPHEN™ V-L CAL (undiluted) CE-IVD aPC res is tance ca l ibration plasma set 222401 3 levels , 3 x 0.5 mL each

BIOPHEN™ Act. PC-r Control Plasma CE-IVD aPC abnormal qual i ty control set. 223405 12 x 0.5 mL


Plasma Protein S control RUOProtein S (free and tota l ) qual i ty control plasma set forELISA method. SC050K 2 levels , 3 x 0.5 mL each


High Positive DDimer Control Plasma RUO Pathologica l concentration (about 2 μg/mL). SC101K 6 x 1 mL

Negative DDimer Control Plasma RUO Concentration less than 0.40 µg/mL. SC102K 6 x 1 mL

DDimer Control Plasma Low RUO Pathologica l concentration (about 0.6 μg/mL). SC103K 6 x 1 mL


LA Control Plasma CE-IVDSet of lyophi l i zed qual i ty control plasmas , weak andhigh pos itive, for use in Lupus Anticoagulant clottingassays .

SC081K C1, C2: 6 x 0.5 mL each

LA Control Plasma Weak CE-IVDSet of lyophi l i zed qual i ty control plasmas , weakpos itive, for use in Lupus Anticoagulant in vi tro clotting assays .

SC082K C1: 6 x 0.5 mL

LA Control Plasma High CE-IVDSet of lyophi l i zed qual i ty control plasmas , highpos itive, for use in Lupus Anticoagulant in vi tro clotting assays .

SC083K C2: 6 x 0.5 mL


FPA control RUO Qual i ty control plasma set for FPA SC015K 2 levels , 3 x 1 mL each

Plasma PAI-1 control RUO Qual i ty control plasma set for PAI-1 SC011K 2 levels , 3 x 1 mL each

Plasma U.T.A. control RUO Qual i ty control plasma set for Annexin V, tPA and uPA SC017K 2 levels , 3 x 1 mL each

Activated Protein C resistance

Protein S

D-Dimers

Lupus Anticoagulant

Fibrinolysis

Direct Thrombin Inhibitors (Continued)

NEW

NEW


Section 1:

Complete line of bu�ers and other auxiliary reagents for hemostasis assays

Section 9: Auxiliary Reagents


Sect

ion

9:

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Section 1:Section 9: Auxiliary Reagents

Description

Description

Description

Buffers & Solutions for Clotting or Chromogenic AssaysProduct Name Description Reference Presentation

AR021A 1 x 25 mLAR021K 3 x 25 mLAR021L 12 x 25 mLAR001A 3 x 25 mLAR001K 12 x 25 mLAR002A 1 x 25 mLAR002K 3 x 25 mLAR026A 3 x 25 mLAR026K 12 x 25 mLAR004A 1 x 50 mLAR004K 3 x 50 mL

Tris-NaCl buffer, pH 7.40 (TBS) RUO Buffers & solutions for clotting & chrom. assays . AR028K 4 x 20 mLAR005A 1 x 50 mLAR005K 3 x 50 mLAR005L 4 x 20 mLAR006A 1 x 50 mLAR006K 3 x 50 mLAR007A 1 x 50 mLAR007K 3 x 50 mLAR008A 1 x 50 mLAR008K 3 x 50 mLAR009A 1 x 50 mLAR009K 3 x 50 mL

Tris NaCl EDTA PEG buffer, 10 x conc. pH 8.4 RUO Buffers for chromogenic assays . AR015A 1 x 10 mL

Tris NaCl EDTA PEG buffer, pH 8.40 RUO Buffers for chromogenic assays . AR030K 4 x 20 mL

Tris NaCl EDTA BSA buffer , pH 8.40 RUO Buffers for chromogenic assays . AR031K 4 x 25 mLAR032A 1 x 20 mLAR032K 4 x 20 mL

Tris EDTA NaCl, pH 8.40 RUO Buffers for chromogenic assays . AR029K 4 x 20 mL

Tris EDTA buffer, 10 x conc. pH 8.40 RUO Buffers for chromogenic assays . AR015B 1 x 20 mL

Tris-BSA buffer, 10x conc. pH 7.30 RUO Buffers for chromogenic assays . AR020A 1 x 20 mL

Prothrombin Activator Diluent RUO Buffers for chromogenic assays . AR022A 1 x 20 mL

AT-Tris buffer Anti-Xa RUO Buffers for chromogenic assays (Progress ive AT). AR103A 1 x 10 mL

AT-Tris buffer Anti-IIa RUO Buffers for chromogenic assays (Progress ive AT). AR104A 1 x 10 mL

Buffers and Solutions for ELISA Product Name Description Reference PresentationDilution buffer RUO Di lution buffer wi th a lbumin for ELISA. AR010A 1 x 50 mL

FPA anticoagulant solution RUO Anticoagulant solution specific for the FPA Assay. AR013A 1 x 20 mLAR011A 1 x 50 mLAR011K 3 x 50 mL

Fibrinolysis Sample Diluent RUO Di luent for Fibrinol ys i s investigation by ELISA. AR016A 1 x 50 mL

ELISA Conjugate Diluent buffer with albumin RUO Conjugate Di luent for ELISA. AR017A 1 x 25 mL

Autoimmunity Sample Diluent RUO Sample Di luent for ELISA. AR018A 1 x 50 mL

Stop solution RUO Stop solution for ELISA. AR019 1 x 6 mL

B2F Sample Diluent (B2GP1/Fibrinogen/Fibronectin)

RUOSample Di luent for ELISA (B2GP1/Fibrinogen/Fibronectin). AR023A 1 x 60 mL

Bentonite suspension RUO Buffers and Solutions for ELISA. AR024A 1 x 50 mL

Other SolutionsProduct Name Description Reference Presentation

223602 10 x 2 mL223605 8 x 5 mL

Tetramethylbenzidine (TMB) substrate RUO ELISA substrates AR012A 1 x 25 mLHigh Sensitivity Tetramenthybenzidine substrate (TMB-HS)

RUO ELISA substrates AR027A 1 x 25 mL

Para-Nitro-Aniline (pNA) RUOStandard solution for control l ing photometers at 405 nm (Reference Material). AR014A 1 x 5 mL

Wash solutionfor microparticle kits

RUOWash Solution for mi croparticle ki t, Zymuphen ™ MP-Activi ty (ref. 521096). AR025A 1 x 50 mL

BIOPHEN™ NormalPlasma CE-IVD

Buffers & solutions for clotting & chrom. assays .

Special Tris-BSA buffer CE-IVD

Wash solution

Pool of normal human Plasma .

Wash solution for ELISA.

Buffers and solutions for clotting assays .

Buffers for chromogenic assays .

Buffers for chromogenic assays .Tris-NaCl buffer, pH 8.4 (I = 0.3) RUO

Buffers and solutions for clotting assays .

Auxiliary Reagents

Calcium Chrol ide solutions for clotting assays .

Buffers for chromogenic assays .(For BIOPHEN® VIII :C, FIX, FIXa )

Imidazole buffer CE-IVD

Calcium Chloride 0.025M (M/40) CE-IVD

Di lution buffers for clotting assays .

Ca lcium Chrol ide solutions for clotting assays . 10 fold concentrated.

Tris buffer, pH 8.4 RUO

Phosphate NaCl (PBS) buffer, pH 7.5 RUO

Phosphate NaCl (PBSA) buffer, pH 7.5 RUO

RUOBuffers and solutions for clotting & chromogenic assays .

Calcium Chloride 0.25M (M/4) CE-IVD

Tris-NaCl buffer, with Albumin - pH 7.40

Tris-NaCl buffer, pH 7.50 (TBS) RUO

Buffers for chromogenic assays .

RUO

Tris NaCl EDTA buffer, pH 7.85 RUO

NEW

NEW


Section 1:Section 10: Research

Research reagents available in kits or as a component (Proteins, enzymes, substrates, etc ) to meet your needs.

HYPHEN BioMed can also develop customized products. If you need a reagent, calibrators and controls for your project, please contact us - we may be able to help you.e-mail: [email protected], Tel: +33 (0)1 34 40 65 10

Customized Products


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Purified ProteinsPurified Human Proteins and EnzymesProduct Name Nature Reference Presentation

EZ004Bon-demand

1 x 10 µg

EZ004C 1 x 100 µg

PP004A 1 x 1 IU*

PP004K 6 x 1 IU*

PP004B 1 x 10 IU*

PP004L 10 x 10 IU*

PP004D 1 x 25 IU*

PP004M 10 x 25 IU*

PP004C 1 x 10 mg

C4b-Binding Protein RUO Human PP015A 1 x 100 µg

Factor VII RUO Human PP013A 1 x 100 µg

Factor IX RUO Human PP007A 1 x 100 µg

Factor IXa RUO Human EZ010B 1 x 100 IU

Factor X RUO Human PP008A 1 x 100 µg

EZ007A 1 x 10 µg

EZ007K 6 x 10 µg

EZ007B 1 x 0.1 mg

EZ007C 1 x 0.5 mg

Factor XIIa RUO Human EZ012Aon-demand

1 x 100 ng

PP001A 1 x 5 mg

PP001K 6 x 5 mg

PP001B 1 x 100 mg

PP001C 1 x 1 g

Fibrinogen, salt free RUO Human PP001R 1 x 100 mg

PP002A 1 x 5 mg

PP002K 6 x 5 mg

PP002B 1 x 100 mg

PP002C 1 x 1 g

Fibrinogen Fragment D RUO Human PP016A 1 x 200 µg

Fibrinogen Fragment E RUO Human PP018A 1 x 200 µg

Fibrin Fragment DD RUO Human PP017A 1 x 200 µg

Fibrin Fragment E (FFE) RUO Human PP020A 1 x 200 µg

EZ014A 1 x 2.5 IU

EZ014Bon-demand

1 x 25 IU

PP005A 1 x 200 µg

PP005B 1 x 1.5 mg

PP005C 1 x 5 mg

Platelet Factor 4 (PF4) RUO Human PP003A 1 x 100 µg

PP501B 1 x 2 mL

PP501K 6 x 2 mL

Protein C RUO Human PP009A 1 x 100 µg

Protein S RUO Human PP012A 1 x 100 µg

Protein Z RUO Human PP011A 1 x 100 µg

Fibrinogen RUO

Fibrinogen, plasminogen free RUO

Activated Protein C RUO

Factor Xa RUO

Anti-Thrombin (AT) RUO

RUOPlasmin

Prekallikrein Pool RUO

Plasminogen RUO

Human

Human

Human

Human

Human

Human

Human

Human

*1 NIH is equivalent to 1 International Unit (IU) (“A reunification of the US (“NIH”) and International Unit into a single standard for Thrombin”, Longstaff et al, Thromb Haemost 2005, 93:261-6).


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Purified Proteins (Continued)Purified Human Proteins and Enzymes (Continued)Product Name Nature Reference Presentation

PP006B 1 x 1 mg

PP006K 6 x 1 mg

EZ006O 1 x 10 NIH*

EZ006K 6 x 10 NIH*

EZ006A 1 x 100 NIH*

EZ006L 10 x 100 NIH*

EZ006B 1 x 1000 NIH*

EZ005Aon-demand

1 x 1,000 uni ts

EZ005Bon-demand

1 x 10,000 uni ts

EZ005Con-demand

1 x 100,000 units

Purified Recombinant Human ProteinsProduct Name Reference Presentation

RP007A 1 x 10 µg

RP007C 1 x 1 mg

RE120A 1 x 16,000 ATU

RE120B 1 x 160,000 ATU

Purified Bovine Proteins & EnzymesProduct Name Nature Reference Presentation

BE101C 1 x 15 µg

BE101D 1 x 30 µg

BE101L 10 x 30 µg

BE101O 1 x 50 µg

BE101K 6 x 50 µg

BE101B 1 x 0.5 mg

Fibrinogen RUO Bovine BP101B 1 x 1 g

BE102A 1 x 21 NIH*

BE102K 6 x 21 NIH*

BE102B 1 x 100 NIH*

BE102C 1 x 1000 NIH*

BE501C 1 x 500 NIH*

BE501K 10 x 500 NIH*

Other EnzymesProduct Name Reference Presentation

Protac® EZ011Bon-demand

1 x 5 uni ts

Rabbit rec. Tissue Factor RE030Aon-demand

1 x 50 µg

Thrombin RUO

Human

Human

Prothrombin RUO

Urokinase type Plasminogen Activator (uPA) RUO

BovineFactor Xa RUO

Recombinant Hirudin RUO

Recombinant human tPA (wi ld type) RUO Human

Human

Human

RUO

RUO

*1 NIH is equivalent to 1 International Unit (IU) (“A reunification of the US (“NIH”) and International Unit into a single standard for Thrombin”, Longstaff et al, Thromb Haemost 2005, 93:261-6).

RUOThrombin Bovine


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Section 1:Section 10: Reseach

Chromogenic Substrates

Description and specificication Reference Presentation

229001 1 x 25 mg

229001C 12 x 25 mg

BIOPHEN™ CS-01(81) Thrombin Chromogenic Substrate RUO 229005 1 x 25 mg

BIOPHEN™ CS-11(32) Factor Xa Chromogenic Substrate RUO 229011 1 x 25 mg

229014 1 x 25 mg

229014C 12 x 25 mg

BIOPHEN™ CS-11(22) Factor Xa Chromogenic Substrate RUO 229015 1 x 25 mg

BIOPHEN™ CS-21(66) Activated Protein C Chromogenic substrate RUO 229021 1 x 25 mg

BIOPHEN™ CS-31(02) Kallicrein Chromogenic substrate RUO 229031 1 x 25 mg

BIOPHEN™ CS-41(03) Plasmin and Plasminogen-SK Chromogenic substrate RUO 229041 1 x 25 mg

BIOPHEN™ CS-61(44) Urokinase Chromogenic substrate RUO 229061 1 x 25 mg

BIOPHEN™ CS-05(88) tPA and broad spectrum Chromogenic substrate RUO 229091 1 x 25 mg

Others

Other Plasma Factor Assay

Product Name Reference Presentation

ZYMUTEST™ Annexin V RUO RK004A 96 tests

ZYMUTEST™ β2GPI RUO RK022A 96 tests

ZYMUTEST™ Fibronectin RUO RK028Aon-demand

96 tests

Other Deficient Plasma

Product Name Reference Presentation

DP200A 1 x 1 mL

DP200K 6 x 1 mL

DP100A 1 x 1 mL

DP100K 6 x 1 mL

DP110A 1 x 1 mL

DP110K 6 x 1 mL

DP150A 1 x 1 mL

DP150K 6 x 1 mL

DP310A 1 x 1 mL

DP310K 6 x 1 mL

Animal ModelsELISA method for PAI-1 antigen and Activity in rat sample.Product Name Reference Presentation

ZYMUTEST™ Rat PAI-1 - Activity RUO RK003A 96 tests

BIOPHEN™ CS-11(65) Factor Xa Chromogenic Substrate RUO

BIOPHEN™ CS-01(38) Thrombin Chromogenic Substrate RUO

Factor XIII Deficient Plasma RUO

Protein C Deficient Plasma RUO

Prekallikrein Deficient Plasma RUO

Protein S Deficient Plasma RUO

vWF Deficient Plasma RUO


A D (continued)Activated Partial Clotting Time (APTT).................6 Dilution buffers....................................................................30Activated Protein C Direct Thrombin Inhibitors (DTI)....................................14

Chromogenic substrate.........................................34 EHuman enzyme........................................................32 Edoxaban (Calibrators & Controls).....................14, 27

Activators (Protac®/Streptokinase)...............................34 Epinephrine .........................................................................20Activator Diluent F

Buffers and solutions for ELISA ..........................30 Factor II ........................................see ProthrombinSolutions for Microparticles.................................30 Factor V

Adenosine-5’-diphosphate (ADP).................................20 Clotting method.......................................................8Aggregometry.....................................................................20 Deficient plasma .....................................................8Alpha 2 anti-plasmin (chromogenic assay)................24 Elisa kit........................................................................8Anti-IIa activity Factor V-Leiden

See Direct Thrombin Inhibitors...........................13 Calibrator...................................................16, 28See Heparins and their analogues............................................................... 12 Clotting method.......................................................16See Thrombophilia ................................................16 Control....................................................16, 28

Anti-VIII Factor VIIElisa kit........................................................................22 Chromogenic assay.................................................8

Anti-Xa activity Clotting method.......................................................8See Direct FXa Inhibitors........................... 13 Deficient plasma......................................................8See Heparins and their analogues..................................12 Elisa kit........................................................................8

Annexin V Human protein.........................................................32Control.......................................................24, 28 Factor VIIaElisa kit.........................................................................34 Chromogenic assay......................................8, 22

Anti-Annexin V auto antibodies.....................................17 Clotting method...........................................8, 22Anti-β2GP1 auto-antibodies...........................................17 Calibrator and control.............................8, 22, 26Anti-cardiolipin/Anti-Phospholipid Factor VII-X (Clotting method).............................8, 9antibodies (ACA/APA)........................................................17 Factor VIII:CAnti-Protein S auto-antibodies...............................17 Chromogenic assay......................................9, 22Anti-Protein Z auto-antibodies.......................................17 Deficient plasma .........................................8, 22Anti-Prothrombin auto-antibodies..............................17 Factor IXAntithrombin III Chromogenic assay.....................................9, 22

Buffers..........................................................................30 Deficient plasma.........................................8, 22Chromogenic assay.................................................16 Elisa kit.......................................................9, 22Latex Immuno-assay...............................................16 Human protein.........................................................32Human protein..........................................................32 Factor IXa

Apixaban (Calibrators & Controls).....................14, 27 Chromogenic assay ......................................9, 22Argatroban (Calibrator & Control).....................14, 27 Chromogenic substrate............................................34Arachidonic Acid.................................................................20 Control.......................................................9, 22, 26Arixtra® (Calibrator & Control).........................12, 26 Human enzyme........................................................34Autoimmunity sample diluent.......................................30 Factor XB Chromogenic assay ...............................................9β2GP1 Deficient plasma....................................................8

Buffer and solutions for ELISA.............................30 Elisa kit.......................................................................9Elisa kit.........................................................................34 Human protein.........................................................32Human protein..........................................................32 Factor Xa

Bentonite................................................................................30 Bovine enzyme........................................................33Bivalirudin (Calibrators & Controls).....................14, 28 Chromogenic assay ....................................12, 13C Chromogenic substrate.....................................34C4b-BP (human protein)...................................................32 Human enzyme........................................................32Calcium Chloride...........................................................30 Factor XICalcium Thromboplastin.....................................................6 Deficient plasma....................................................8Calibrators..............................................................................25 Factor XIaCollagen..................................................................................20 Chromogenic assay .............................................9Collagen Binding Assay (CBA) ........................................22 Control.......................................................9, 22, 26Control plasmas..................................................................25 Factor XIIConjugate Diluent...............................................................30 Deficient plasma......................................................8C-Reactive Protein (CRP) Factor XIIa

Elisa kit.........................................................................18 Human Enzyme........................................................32D Factor XIIIDabigatran (Calibrators & Controls).....................14, 27 Deficient plasma.....................................................34D-Dimer Chromogenic assay ................................................9

Controls.................................................................28 Elisa kit.........................................................................9Elisa kit...............................................................18 Fibrin (fragment)..................................................................32

Deficient Plasmas......................................................8, 22, 34 Fibrinolysis sample diluent..............................................30IND

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Section 1:INDEX - by Product Name

F (continued) P (continued)Fibrino Peptide A (FPA) Protein C

Buffer and solutions for ELISA.............................30 Chromogenic assay.................................................16Elisa kit.........................................................................18 Clotting method.......................................................16Control.........................................................................28 Deficient plasma......................................................34

Fibrinogen Elisa kit.........................................................................16Bovine protein..........................................................32 Human protein.........................................................32

see Prothrombin Buffer and solutions for ELISA.............................30 Protein SElisa kit.....................................................................6 Clotting method......................................................16Human protein..................................................32 Control.........................................................................28Fragments D, DD, E ......................................32 Deficient plasma......................................................34Latex immuno-assay...........................................6 Elisa kit ....................................................................16Von Clauss Method...................................................6 Human protein.........................................................32

Fibronectin Latex Immuno-assay..............................................16Elisa kit.........................................................................34 Protein ZBuffer and solutions for ELISA.............................30 Elisa kit.........................................................................16

H Human protein..........................................................32Heparin Prothrombin

Chromogenic assay........................................12 Buffer and solutions................................................30Calibrators and Controls..............................12, 26 Deficient plasma......................................................8

Heparin dependent antibodies (Elisa kit)....... 14 Human protein..........................................................8133Hirudin Prothrombin Time (PT)

Calibrators and Control.............................14, 28 Clotting method..........................................................6Recombinant Hirudin............................................33 R

I Ristocetin.......................................................20, 22Imidazole buffer..................................................................30 Rivaroxaban (Calibrators & Controls)..................13, 27K SKallikrein (Chromogenic substrate)..............................34 Sample Diluents............................................................30L Stop Solution........................................................................30Low Molecular Weight Heparin Substrates.......................................................30, 34

Calibrators and Controls............................12, 26 TLupus Anticoagulant Thrombin Activatable Fibrinolysis Inhibitor (TAFI)

Clotting method................................................17 Elisa kit........................................................................24Controls....................................................17, 28 Thrombin

Lyophilized platelets.......................................20, 22 Bovine enzyme.........................................................33M Chromogenic substrate.........................................34Microparticles’ coagulant activity.................................18 Clotting method.........................................................6N Human enzyme.......................................................33Non titrated human plasmas (Chromogenic assay)...........5130 Thrombin Time (T.T.)............................................................6O Tissue FactorOrgaran® (Calibrator & Control).......................12, 26 Elisa kits................................................................18P Recombinant, rabbit...............................................33Phosphate-NaCl buffers....................................................30 Tissue Plasminogen Activator (tPA)Plasminogen Activator Inhibitor-1 (PAI-1) Elisa kits (Antigen & Activity)........................24

Control.......................................................24, 28 Control.....................................................24, 28Elisa kit (Activity & Antigen)...........................24 Recombinant human protein.............................33Elisa kit (Animal model)..........................................34 tPA and broad spectrum (Chrom. Substrate).......34Protein (Animal model)..........................................34 Tetra-Methyl Benidine (TMB)..........................................30

Platelet aggregation...................................................20 Tris buffers..............................................................................30Para-Nitro-Aniline (PNA)...................................................30 UPlasma factors and cofactors (Chromogenic assay) .........................................................26 Unfractionated HeparinPlasmin Calibrators and Controls............................12, 26

Chromogenic substrate....................................................34 Urokinase (Chromogenic substrate)............................34Human enzyme...................................................................32 Urokinase-type Plasminogen Activator (uPA)

Plasminogen Control.......................................................24, 28Chromogenic assay..........................................24 Elisa kits..................................................................24Human protein..........................................................32 Human enzyme.....................................................33

Platelet Factor 4 (PF4) V Control.........................................................................20 von Willebrand Factor (vWF)Elisa kit.........................................................................20 Deficient plasma..................................................34Human protein.........................................................32 Elisa kit.......................................................................22

Prekallikrein Latex immuno-assay...........................................22Deficient plasma......................................................34 WHuman protein..........................................................32 Wash solutions..............................................................30

Protac® ...................................................................................33

IND

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Section 1:INDEX - by Product Name -


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Section 1:INDEX - by Reference Number -

BIOPHEN™ line BIOPHEN™ line (continued) ZYMUTEST™ line (continued) Bovine Proteins220005..........................................................................12 229011................................................................……………………….34 RK023A...............................................................26............18 BP101B.................................................86.........33220202..........................................................................13 229014/C...........................................................……………………….34 RK024A...............................................................73...........................6 Deficient plasmas220412............................................................................9 229015................................................................……………………….34 RK025A/B....................................................................17 DP010A/K.............................................................................8220502..........................................................................24 229021................................................................……………………….34 RK027A........................................................................16 DP020A/K.............................................................................8221003/221006.........................................................12, 13 229031................................................................……………………….34 RK028A........................................................................34 DP030A/K.............................................................................8221005..........................................................................12 229041................................................................75……………………….34 RK029A/B...............................................................17 DP040A/K...................................................................8, 22221007..........................................................................12 229061................................................................76……………………….34 RK030A...............................................................15.........22 DP050A/K..........................................................17.........8, 22221011/221013/221015.........................................................12, 13 229091................................................................76……………………….34 RK031A...............................................................24.........16 DP060A/K..........................................................17...................8221020..........................................................................12 Aggregometry line RK032A...............................................................13.........9, 22 DP070A/K..........................................................17...................8221030................................................................…………...13 AG001K..............................................................67……………....20 RK033A...............................................................14.........9 DP080A/K..........................................................18...................8221102/221105...............................................………………...16 AG002K..............................................................67……………....20 RK034A...............................................................15.........9 DP100A/K..........................................................19….........34221122................................................................………………...16 AG003K..............................................................67……………....20 RK035A...............................................................70.........18 DP110A/K..........................................................19….........34221123/221127...............................................................………………...16 AG004K..............................................................68............20, 22 RK036A...............................................................11.........8 DP150A/K..........................................................19….........34221205...............................................………………...16 AG005K..............................................................68……………....20 RK037A...............................................................63.........24 DP200A/K..........................................................18….........34221211................................................................………………...16 AG006A/K...............................................................68.........20, 22 RK038A...............................................................15.........22 DP310A/K..........................................................18….........34221304............................................................................8 CEPHEN™ line RK039A...............................................................13.........22 Human Enzymes221312......................................................................8, 22 CK511K/CK512K................................................6.................6 RK040A...............................................................31.........14 EZ004B/C......................................................84...............32221402/221406.....................................................8, 22 CK515K/L..............................................................6.................6 RK040B...............................................................31.........14 EZ005A/B/C......................................................85..................33221511................................................................………………...24 CK521K/CK522K................................................7.................6 RK040C...............................................................31.........14 EZ006O/K/A/L/B..............................................84................33221705............................................................................9 FIBRIPHEN™ line RK040D...............................................................32.........14 EZ007A/K/B/C..............................................84...............32221801/221802/221806.....................................................9, 22 CK571K/CK572K/CK575K..............................6 RK040E...............................................................32.........14 EZ010B...............................................................84...............32221812............................................................................9 CK585K..........................................................6 RK041A...............................................................33.........14 EZ011B...........................................................88………….......33222001.........................................................................12, 26 HEMOCLOT™ line RK041D...............................................................33.........14 EZ012A...........................................................84...............32222101.........................................................................26 CK001K/L..............................................................7.................6 RK042A...............................................................71.........18 EZ014A/B...........................................................84...............32222201.........................................................................12, 26 CK002K/L...........................................................34.............13 Auxiliary reagents Purified Proteins222301.........................................................................12, 26 CK011K/L..............................................................7.................6 AR001A/K..........................................................57.........30 PP001A/K/B/C/R..............................................78...............32222401.........................................................................16, 28 CK012K..............................................................7.................6 AR002A/K..........................................................58.........30 PP002A/K/B/C..................................................79...............32222501.........................................................................12, 26 CK031K...............................................................23............16 AR004A/K..........................................................58.........30 PP003A...............................................................82...............32222701.........................................................................13, 27 CK041K/CK042K...............................................................23............16 AR005A/K/L ........................................................58.........30 PP004A/K/B/L/D/M/C....................................78...............32222801.........................................................................14, 27 CK051K/L...........................................................12.........8, 9 AR006A/K..........................................................58.........30 PP005A/B/C......................................................80...............32222901.........................................................................14, 27 CK065K...............................................................25............16 AR007A/K..........................................................58.........30 PP006B/K...........................................................81........33223001/223801/224201........................................12, 26 CK071K...............................................................10...................8 AR008A/K..........................................................56.........30 PP007A...............................................................81...............32223101/223901/224101........................................12, 26 CK081K...............................................................11...................8 AR009A/K...................................................................30 PP008A...............................................................81...............32223201.........................................................................26 CK090K/CK094K........................................................ 26, 36............17 AR010A...............................................................59.........30 PP009A...............................................................82...............32223301.........................................................................26 CK091K........................................................ 27, 36............17 AR011A/K..........................................................59.........30 PP011A...............................................................82...............32223405.........................................................................16, 28 CK092K........................................................ 27, 36.........8, 22 AR012A...............................................................56.........30 PP012A...............................................................82...............32223501.........................................................................12, 26 LIAPHEN™ line AR013A...............................................................59.........30 PP013A...............................................................81...............32223602/223605........................................................30 120002................................................................22............16 AR014A...............................................................56.........30 PP015A...............................................................78...............32223701/224301/224401........................................12, 26 120004................................................................22............16 AR015A..........................................................56.........30 PP016A...............................................................79...............32224001.........................................................................12, 26 120102................................................................72…………..........6 AR015B..........................................................56.........30 PP017A...............................................................79...............32224501.........................................................................13, 27 120206...............................................................72............22 AR016A...............................................................59.........30 PP018A...............................................................79...............32224601.........................................................................9, 22, 26 PT-phen™ line AR017A...............................................................59.........30 PP020A...............................................................80...............32224701.........................................................................14, 27 CK581/CK582/CK583.........................................................6…………..........6 AR018A...............................................................59.........30 PP501B/K...........................................................80...............32224801.........................................................................9, 22, 26 ZYMUPHEN™ line AR019...............................................................60.........30 Recombinant Human Proteins224901.........................................................................8, 22, 26 521096................................................................27.........18 AR020A...............................................................57.........30 RP007A/C..........................................................83.................33225001.........................................................................14, 27 521196................................................................27.........18 AR021A/K/L......................................................58.........30 Recombinant Proteins225101.........................................................................13, 27 521296................................................................64.........24 AR022A...............................................................57.........30 RE030A...............................................................88……….........33225201.........................................................................13, 27 ZYMUTEST™ line AR023A...............................................................60.........30 RE120A/B...............................................................93............33225301.........................................................................13, 27 RK003A...............................................................92….........34 AR024A...............................................................60.........30 Standard and Controls225401.........................................................................13, 27 RK004A...............................................................72….........34 AR025A...............................................................60.........30 SC011K...............................................................51........24, 28225501.........................................................................13, 27 RK005A/B...........................................................39.............17 AR026A/K..........................................................57.........30 SC013K...............................................................52……….........20225601.........................................................................26 RK006A...............................................................71.............20 AR027A...............................................................56.........30 SC015K...............................................................52............28225701.........................................................................14, 28 RK007A/B...........................................................42.............17 AR028K...............................................................57.........30 SC017K...............................................................52............24, 28226001.........................................................................13, 27 RK008A...............................................................63.............24 AR029K...............................................................58.........30 SC020K/L...........................................................49.........14, 28226101.........................................................................13, 27 RK009A...............................................................10..................8 AR030K...............................................................58.........30 SC025K...............................................................50.........14, 28226201.........................................................................13, 27 RK010A...............................................................70............18 AR031K...............................................................59.........30 SC030K...............................................................49.........14, 27226301....................................................................22, 26 RK011A...............................................................64.............24 AR032A/K...............................................................60.........13, 30 SC035K...............................................................49.........14, 27226401.........................................................................13, 27 RK012A...............................................................62.............24 AR103A...............................................................57.........30 SC050K...............................................................53..................28226501.........................................................................13, 27 RK014A/B......................................................38............17 AR104A...............................................................57.........30 SC081K...............................................................36.........17, 28226601....................................................................26 RK015B...............................................................24..............16 SC082K...............................................................36.........17, 28226701.........................................................................14, 28 RK016A...............................................................26............18 Bovine Enzymes SC083K...............................................................36.........17, 28227005...........................................................……………………….9 RK019A...............................................................62................24 BE101C/D/L/O/K/B.........................................87.........33 SC101K...............................................................53…………........28229001/C........................................................................34 RK020A/B...........................................................40............17 BE102A/K/B/C/................................................87.........33 SC102K...............................................................53…………........28229005.............................................................................34 RK022A...............................................................72............34 BE501C/K...........................................................87.........33 SC103K...............................................................53…………........28

HYPHEN BioMed S.A.S. 155 rue d’Eragny 95000 NEUVILLE-SUR-OISE France • Tél: +33 (0)1.34.40.65.10 • Web : www.hyphen-biomed.com

Lire attentivement les instructions figurant sur l’étiquetage et/ou la notice d’utilisation des réactifs.Read carefully the instructions appearing on the label and / or instructions for use of the reagents.

HYPHEN BioMed155 rue d’Eragny, 95000 Neuville-sur-Oise, France • Tel: +33 (0)1.34.40.65.10 • [email protected] • www.hyphen-biomed.com

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