new poct solution · sales of rapid diagnostic reagents and related equipment in ivd (in vitro...

NEW POCT SOLUTION

PRODUCT CATALOG 2020

WONDFO PROFILEGuangzhou Wondfo Biotech Co., Ltd., located in Guangzhou, China, is a globally

recognized fast growing POCT company devoted to the R&D, manufacture and

sales of rapid diagnostic reagents and related equipment in IVD (in vitro diagnostic)

field.

Founded in 1992, the company is continually expanding its scale. Apart from the

Guangzhou headquarters, Wondfo also owns two overseas R&D center, one branch

in Chicago and more than ten overseas offices. Wondfo went public in June, 2015

(Stock Code: 300482), and has more than 1,500 employees.

As one of the earliest high-tech biological companies focusing on rapid diagnostics

for toxicology, infectious diseases, fertility, cardiovascular disease, tumor,

respiratory disease, renal injury and diabetes. Wondfo has won good reputation

around the world. In addition, Wondfo has got CE certificates, FDA certificates, FSC

certificates, ISO 9001:2015 and ISO 13485:2016 quality system certification.

We are dedicated to making the world a better place by providing people with high

quality products and services.

Stock Code: 300482

Wondfo has been consistently paying attention to R&D and regarding innovation as the core

of its development. As a result, there are highly educated employees in the company. And it

owns 4 well-equipped research laboratories all over the world.

Professional R&D Team

With the international leading production lines and highly experienced staff, its daily

production capacity reaches to 1.5 million test strips. Services are also tailored to professional

distributors and partnering affiliates.

Strong Production Capacity

Covering more than 180 countries and areas, Wondfo provides an exciting opportunity to

distribute quality products at very competitive price. Every aspect of the company’s operation

is strictly measured, which provides customers with all-around technical support and

counselling all the time.

Integrated Services System

01

02

03

Focus on IndustryPOCTCardiovascular

Diabetes

Fertility

DOA Infection

Tumor

Renal Injury

Respiratory

PharmacyDrugstore

Laboratory HospitalClinicGP Office

Anti-drug

8Major fields

Applications

CERTIFICATES

Guangzhou Wondfo Biotech Co., Ltd.

ISO 13485 ISO9001 CE FDA

CONTENTSQualitative Rapid Diagnostic Family

Fertility Tests

hCG Pregnancy TestSperm Concentration TestLH Ovulation TestFSH Urine Test

Infectious Disease Tests

SARS-CoV-2 Ag/Ab TestHBsAg Hepatitis B Surface Antigen TestHBV Hepatitis B Virus TestHBsAb Hepatitis B Surface Antibody TestHCV Hepatitis C Virus TestHIV 1/2 Blood Test (2 Lines)HIV 1/2 Blood Test (3 Lines)HIV 1/2 Oral Mucosal Transudate TestMalaria P.f TestMalaria P.f/Pan TestMalaria P.f/P.v TestH.Pylori TestFlu A TestFlu B TestFlu A&B TsetDengue NS1 Antigen TestDengue IgG/IgM Antibody TestCombined Dengue NS1 Antigen and Dengue IgG/IgM Antibody TestHAV Hepatitis A Virus TestHEV Hepatitis E Virus TestHIV-HCV-HBsAg-Syphilis TestHIV-HCV-HBsAg-HBcAb-Syphilis TestSyphilis TestSyphilis-HIV TestChlamydia TestAdenovirus TestRotavirus TestStrep A Test

Tumor Marker Tests

FOB Fecal Occult Blood TestPSA Prostate Specific Antigen Test

02

03

04

Drug of Abuse Tests (Urine)

AMP Amphetamine Test BAR Barbiturates TestCAF Caffeine TestBZO Benzodiazepines TestCOC Cocaine TestMET Methamphetamine TestMDMA TestBUP Buprenorphine TestMOP Morphine Test MTD Methadone TestOPI Opiate TestPCP Phencyclidine TestTCA Tricyclic Antidepressants TestTHC Marijuana TestOXY Oxycodone TestKET Ketamine TestPPX Propoxyphene TestEDDP TestTRA Tramadol TestK2 Synthesis Cannabis TestFTY Fentanyl TestCOT Cotinine TestETG Ethylgl Ucuronide TestMQL Methaqualone Test

Multi-Drug Tests

Multi-Drug 6 TestMulti-Drug T-CubeMulti-Test PanelMulti-Test T-CupMulti-Test Q-CupMulti-Test K-CupMulti-Test T-Cup PlusMulti-Test Q-Cup Plus

Other Rapid Tests

Urinalysis Reagents StripTroponin I TestAlcohol Saliva Test

Quantitative Detection FamilyDry Chemistry Analyzer

Blood Gas Analyzer

Optical Coagulation Analyzer

Blood Glucose Monitoring System

Quantitative Detection Family

Immunofluorescence Quantitative Test System

06

08

09

07-1107

06

04-06

09

10

11

Qualitative Rapid Diagnostic Family

● Infectious Disease Tests

● Tumor Marker Tests

● Alcohol Tests

● Cardiac Tests

● Urinalysis Reagents Strip

● Fertility Tests

● DOA Urine Tests

● DOA Urine Tests

T-Cup Key-CupQ-CupPanel

Sperm Concentration Test KitPregnancy & Ovulation tests

DM-102 (Disposable)

Digital Pregnancy Test

Strip

Cassette

● DOA Oral Fluid Tests

DOA Oral Fluid TestsT-Cup Plus (Applicable with Vacuum Tube)

Qualitative Tests

CT

Fertility Tests: Ovulation Tests

Cat. No. Test Item Format Width Specimen Sensitivity Qualification

W2-S

W2-C

W2-C I

W2-M

W2-M II

W2-M4

W2-M6

W52-S

W52-C

W52-M

LH Ovulation Test

LH Ovulation Test

LH Ovulation Test

LH Ovulation Test

LH Ovulation Test

LH Ovulation Test

LH Ovulation Test

FSH Urine Test

FSH Urine Test

FSH Urine Test

Strip

Cassette

Cassette

Midstream

Midstream

Midstream

Midstream

Strip

Cassette

Midstream

2.5/3.0/3.5 mm

4.0 mm

3.5 mm

6.0 mm

5.0 mm

3.5 mm

6.0 mm

2.5/3.0/3.5 mm

4.0 mm

6.0 mm

Urine

Urine

Urine

Urine

Urine

Urine

Urine

Urine

Urine

Urine

25 mIU/mL

25 mIU/mL

25 mIU/mL

25 mIU/mL

25 mIU/mL

25 mIU/mL

25 mIU/mL

25 mIU/mL

25 mIU/mL

25 mIU/mL

0123

0123

Fertility Test: Pregnancy Tests

Cat. No. Test Item Format Width Specimen Sensitivity Qualification

W1-S

W1-C

W1-C I

W1-M

W1-M II

W1-M III

W1-M4

W1-M6

W1-S3P

W1-C3P

DM-102

W121-S

W121-C

hCG Pregnancy Test

hCG Pregnancy Test

hCG Pregnancy Test

hCG Pregnancy Test

hCG Pregnancy Test

hCG Pregnancy Test

hCG Pregnancy Test

hCG Pregnancy Test

hCG Pregnancy Test

hCG Pregnancy Test

Digital Pregnancy Test (Diposable)

Sperm Concentration Test

Sperm Concentration Test

Strip

Cassette

Cassette

Midstream

Midstream

Midstream

Midstream

Midstream

Strip

Cassette

Midstream

Strip

Cassette

2.5/3.0/3.5/4.0 mm

4.0 mm

3.5 mm

6.0 mm

5.0 mm

6.0 mm

3.5 mm

6.0 mm

2.5/3.0 mm

4.0 mm

6.0 mm

2.5/3.0/3.5 mm

4.0 mm

Urine

Urine

Urine

Urine

Urine

Urine

Urine

Urine

Urine/Serum

Urine/Serum

Urine

Semen

Semen

25/20/10 mIU/mL

25/20/10 mIU/mL

25/20/10 mIU/mL

25/20/10 mIU/mL

25/20/10 mIU/mL

25/20/10 mIU/mL

25/20/10 mIU/mL

25/20/10 mIU/mL

25 mIU/mL

25 mIU/mL

25 mIU/mL

15x106 /mL

15x106 /mL

0123

0123

CLIA WAIVED0123

CLIA WAIVED0123

CLIA WAIVED0123

CLIA WAIVED0123

CLIA WAIVED0123

CLIA WAIVED0123

CLIA WAIVED0123

CLIA WAIVED0123

CLIA WAIVED0123

CLIA WAIVED0123

CLIA WAIVED0123

CLIA WAIVED0123

CLIA WAIVED0123

CLIA WAIVED0123

CLIA WAIVED0123

CLIA WAIVED0123

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED0123

Infectious Disease Tests

Qualitative Tests

S/P/WB

S/P/WB

S/P/WB

S/P/WB

S/P/WB

S/P/WB

S/P/WB

S/P/WB

S/P/WB

S/P/WB

S/P/WB

S/P/WB

S/P/WB

S/P/WB

S/P/WB

Oral Mucosal Transudate

Whole Blood

S/P/WB

S/P/WB

Swab/Urine

Swab

Whole Blood

Whole Blood

Whole Blood

Whole Blood

Feces

Serum/Plasma

Serum/Plasma

Nasal Swab/Throat Swab



S/P/WB

S/P/WB

S/P/WB

Feces

Feces

Swab

Cassette

Cassette

Strip

Cassette

Strip

Panel

Cassette

Strip

Cassette

Cassette

Cassette

Cassette

Cassette

Cassette

Cassette

Cassette

Cassette

Strip

Cassette

Cassette

Cassette

Cassette

Strip

Cassette

Cassette

Cassette

Cassette

Strip

Cassette

Cassette

Cassette

Cassette

Cassette

Cassette

Cassette

Cassette

Cassette

Test ItemCat. No. Category Specimen Format Sensitivity Qualification

4 IU/mL

4 IU/mL

30 mIU/mL

30 mIU/mL

/

2 NCU/mL

2 NCU/mL

/

/

/

/

/

/

/

/

2 NCU/mL

2 NCU/mL

2 NCU/mL

5×104 IFU/mL

1×105 CFU/mL

100 p/μL

100 p/μL

100 p/μL

100 p/μL

/

/

/Flu A: 5.1×105 TCID50/mL Flu B: 1.5×106 TCID50/mL

Flu A: 5.1×105 TCID50/mL

Flu B: 1.5×106 TCID50/mL

/

/

/

/

/

/

W195

W003-C

W003-S

W004-C

W004-S

W040-P

W005-C

W005-S

W071-C

W072-C

W026-C

W61-P

W006-C4P2

W752-C4G3

W050-C

W063-C

W107

W34-S4P

W34-C4P

W35-C

W036

W37-C

W37-S

W056-C

W62-C

W028-C

W38-C

W38-S

W71-C

W72-C

W73-C

W109-C

W041-C

W111

W112-C

W133-C

W39-C

SARS-CoV-2 Ab

HBsAg

HBsAg

HBsAb

HBsAb

HBV(HBsAg, HBsAb, HBeAg, HBeAb, HBcAb)

HCV

HCV

HAV-IgM

HEV-IgM

HIV-HCV-HBsAg-Syphilis Test

HIV-HCV-HBsAg-HBcAb-Syphilis Test

HIV 1/2(2 Lines)

HIV 1/2(2 Lines)

HIV 1/2(3 Lines)

HIV 1/2 Oral Mucosal Transudate Test

Syphilis-HIV

Syphilis

Syphilis

Chlamydia

Gonorrhea

Malaria HRP2(P.f)

Malaria HRP2(P.f)

Malaria HRP2/pLDH(P.f/P.v)

Malaria HRP2/pLDH(P.f/Pan)

H.Pylori Antigen

H.Pylori Antibody

H.Pylori Antibody

Flu A&B

Flu A

Flu B

Dengue IgG/IgM Antibody Test

Dengue NS1 Antigen Test

Combined Dengue NSI Antigen and IgG/IgM Antibody Test

Rotavirus Test

Adenovirus Test

Strep A

PQ

CLIA WAIVED

CFDA

Hepatitis

COVID-19

HIV

STD

Malaria

H.Pylori

Flu

Dengue

Others

/

Tumor Marker TestsCat. No. Test Item Format Width Specimen Sensitivity Qualification

W31-S

W31-C

W030-C

W30-S

W30-C

PSA

PSA

FOB

FOB

FOB

Strip

Cassette

Cassette

Strip

Cassette

2.5/3.0 mm

4.0 mm

4.0 mm

2.5/3.0/4.0 mm

4.0 mm

Serum/Plasma

Serum/Plasma

Feces

Feces

Feces

/

/

50 ng/mL

200 ng/mL

200 ng/mL

Drug of Abuse Tests (Urine)Cat. No. Product Format Specimen Sensitivity

AMP (Ampthetamine)

BAR (Barbiturates)

BZO (Benzodiazepines)

COC (Cocaine)

mAMP/MET (Methamphetamine)

MDMA (MDMA)

BUP (Buprenorphine)

MOP (Morphine)

MTD (Methadone)

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

W7-S

W7-C

W7-P

W8-S

W8-C

W8-P

W9-S

W9-C

W9-P

W10-S

W10-C

W10-P

W11-S

W11-C

W11-P

W12-S

W12-C

W12-P

W13-S

W13-C

W13-P

W14-S

W14-C

W14-P

W15-S

W15-C

W15-P

Width

3.0/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

1000/500/300 ng/mL

1000/500/300 ng/mL

1000/500/300 ng/mL

300/200 ng/mL

300/200 ng/mL

300/200 ng/mL

300/200/100 ng/mL

300/200/100 ng/mL

300/200/100 ng/mL

300/150/100 ng/mL

300/150/100 ng/mL

300/150/100 ng/mL

1000/500 ng/mL

1000/500 ng/mL

1000/500/300 ng/mL

1000/500 ng/mL

1000/500 ng/mL

1000/500 ng/mL

10 ng/mL

10 ng/mL

10 ng/mL

500/300/100 ng/mL

500/300/100 ng/mL

500/300/100 ng/mL

300/200 ng/mL

300/200 ng/mL

300/200 ng/mL

Qualification

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED0123

0123

0123


PAGE 05

Qualitative Tests

Product Format Specimen Sensitivity

OPI (Opiate)

PCP (Phencyclidine)

TCA (Tricyclic Antidepressants)

THC (Marijuana)

OXY (Oxycodone)

KET (Ketamine)

PPX (Propoxyphene)

EDDP (EDDP)

TRA (Tramadol)

FTY (Fentanyl)

K2 (Synthetic Cannabis)

COT (Cotinine)

ETG (Ethyl Glucuronide)

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

Strip

Cassette

Panel

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

urine

Width

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

2000/300/100 ng/mL

2000/300/100 ng/mL

2000/300/100 ng/mL

25 ng/mL

25 ng/mL

25 ng/mL

1000 ng/mL

1000 ng/mL

1000 ng/mL

50/40/25 ng/mL

50/40/25 ng/mL

50/40/25 ng/mL

100 ng/mL

100 ng/mL

100 ng/mL

1000/300 ng/mL

1000/300 ng/mL

1000/300 ng/mL

300 ng/mL

300 ng/mL

300 ng/mL

300/100 ng/mL

300/100 ng/mL

300/100 ng/mL

1000/200 ng/mL

1000/200 ng/mL

1000/200 ng/mL

20 ng/mL

20 ng/mL

20 ng/mL

50 ng/mL

50 ng/mL

50 ng/mL

100 ng/mL

100 ng/mL

100 ng/mL

500 ng/mL

500 ng/mL

500 ng/mL

QualificationCat. No.

W16-S

W16-C

W16-P

W17-S

W17-C

W17-P

W18-S

W18-C

W18-P

W19-S

W19-C

W19-P

W21-S

W21-C

W21-P

W55-S

W55-C

W55-P

W57-S

W57-C

W57-P

W074-S

W074-C

W074-P

W086-S

W086-C

W086-P

W087-S

W087-C

W087-P

W089-S

W089-C

W089-P

W139-S

W139-C

W139-P

W140-S

W140-C

W140-P

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED

CLIA WAIVED


PAGE 06

Multi-Drug Tests

Other Rapid Tests

Product Format Width Specimen Sensitivity

CAF (Caffeine)

MQL(Methaqualone)

Strip

Cassette

Panel

Strip

Panel

2.5/3.0/3.5/4.0 mm

4.0 mm

4.0 mm

4.0 mm

4.0 mm

W083-S

W083-C

W083-P

W155-S

W155-P

Urine

Urine

Urine

Urine

Urine

Variable

Variable

Variable

Variable

Variable

QualificationCat. No.

Test itemsProductCat. No. Format Specimen Sensitivity

Oral Fluid Multi-Drug 6 Test

Multi-Drug T-Cube Test

6 Items

2-10 Items

2-12 Items

13-16 Items

2-18 Items

2-18 Items

2-18 Items

2-18 Items

W6506

W602~610-CU6

W200X(2-12)-P

W200X(13-16)-P

W50X(2-18)-CU2

W50X(2-18)-CU3

W50X(2-18)-CU8

W50X(2-18)-CU7

Cassette

T-Cube

Panel

Panel

T-Cup

Q-Cup

T-Cup Plus

Q-Cup Plus

/

3.0 mm

4.0 mm

4.0 mm

2.5 mm

2.5 mm

2.5 mm

2.5 mm

Oral Fluid

Oral Fluid

Urine

Urine

Urine

Urine

Urine

Urine

Variable

Variable

Variable

Variable

Variable

Variable

Variable

Variable

/

/

(AMP/BZO/COC/THC/MET/MOP)

CLIA WAIVED

Width Qualification

ProductCat. No. Format Specimen SensitivityWidth Qualification

W5410-S

W46-C4P

W53-S

Urinalysis Reagents Strip(1~10 Parameter)

Troponin I Test

Alcohol Saliva Test

Strip

Cassette

Strip

5.0 mm

4.0 mm

3.5/4.0 mm

Urine

S/P/WB

Oral Fluid

/

1 ng/mL

Custom

Urine Multi-Drug Test

NewDry Chemistry Analyzer

● Liver Function

● Kidney Function

● Emergency Diagnosis

● Myocardial Enzyme

● Blood Routine Examination

● Blood Glucose

DC-101

Advanced reflective photometrymethod ensuresaccurate result, good correlationwith reference method.

· Small& Portable· Required less sample volume≤20 μL

· 60 tests per hour· Result comes out in 1-5 min(s)

· One step loading· Full-touch screen, user-friendly interactive system.

ACCURATE FLEXIBLE RAPID EASY-TO-USE ECONOMY

· Single test, free combination, no waste.· No pipeline system, maintainance free.

Test Item

Onging: TP, TBIL，DBIL, TBA, G6PD; TC, TG, LDL-C, HDL-C, DAO, D-LAC, BET, NH3

Liver Function

Kidney Function

Myocardial Enzyme

Emergency Treatment

Blood Routine Examination

Blood Glucose

ALT

AST

ALB

UREA

CREA

UA

CK

CK-MB

LDH

a-HBDH

α-AMY

LPS

CHE

ALC

HB

GLU

Serum/Plasma

Serum

Serum

Serum/Plasma

Serum

Serum/Plasma

Serum

Serum

Serum

Serum

Serum/Urine

Serum

Serum

Serum

Whole Blood

Serum

2.5

2

1

2

5

2

3

4

2

2

2

3

2

2

1

2

15

15

15

15

15

15

15

15

15

15

10

10

15

15

10

15

5-800 U/L

10-800 U/L

10-60 g/L

2.5-40 mmol/L

30-1500 μmol/L

120-1200 μmol/L

20-1600 U/L

5-300 U/L

100-1800 U/L

20-1000 U/L

20-2000 U/L

5-900 U/L

200-12500 U/L

10.0-300.0 mg/dL

45-200 g/L

1.00-25.00 mmol/L

W416

W420

W414

W412

W418

W413

W422

W423

W419

W426

W411

W424

W417

W421

W415

W425

Catalog No. Category Test Item Sample Type Reaction Time(min) Sample Volume(μL) Measuring Range

Blood Gas Analyzer

pH, pCO2, pO2, K+, Na+, Ca++, Cl-, Hct, Glu, Lac

Calculation Parameters: cH+, cH+(T), pH(T), pCO2(T), pO2(T), HCO3-atd, HCO3

-std, BB(B), BE(B),

BE(ecf), ct CO2, Ca++(7.4), AnGap, tHb(est), sO2(est), pO2(A-a), pO2(A-a)(T), pO2(a/A),

pO2(a/A)(T), RI, RI(T), pO2/FI O2, pO2(T)/FI O2

Specifications:

● Sample Type: Whole Blood

● Sample Volume: 80 μL

● Reading Time: 30 s

● Suitable for Syringe and Capillary

● Memory:>50,000

● Good Correlation to Reference Method: R2>0.95

● Test card is stable and effective for 15 months

● Reagent pack can be used for up to 60 days

after installation

BGA-101

Test ItemCat No. W459

···

W465

········

W463

·····

··

W464

······

·

W462

·····

·

W460

··

·

W461

····

W466

··

·

·

··

····

pH

CO2

O2

K

Na

Ca

Cl

H

Glu

Lac

ct

+

+

+

-

+

p

p

Test Packages

Quantitative Tests

Cat. No. Item Specimen Specification Qualification

OCG-102

W480-484


PT(INR)/APTT/TT/FIB/ACT

/

Citrated Venous Whole Blood and Capillary Blood (PT/INR only）

/

24 T/Kit

● Glucose Meter

Blood GlucoseMonitoring SystemBlood GlucoseMonitoring System

900 Memories900

Fast Test

Less Blood Sample

Automatic Temperature Adjust

under room temperature.

Authorized Distributor:

Manufactured for：

Wondfo USA Co., Ltd

825 W 75th St,

Unit B Willowbrook

IL 60527

Qarad b.v.b.a.

Volmolenheide 13

B-2400 Mol, Belgium

E C REP

Storage:

Store the meter, control solution, test strips

Operation Temperature:10-40℃

Please read user's manual carefully before testing.

This product is suitable for self-testing.

Blood GlucoseMonitoring SystemBlood GlucoseMonitoring System

Cat. No. Item Specimen Sample Volume

WM801W02

W301


Blood Glucose Test Strip

/

Capillary Whole Blood

/

8 μL



PT/INR, APTT, TT, FIB, ACT

Specifications:

● Sample Type: Citrated Venous Whole Blood or

Capillary Blood (PT/INR Only)

● Sample Volume: 20 μL

● Time to Result: ≤5 minutes

● Precision: CV≤5%

● Store at room temperature and valid for 18 months

OCG-102

FinecareTM FIA Meter (FS-112)

FinecareTM FIA Meter Plus (FS-113)

FinecareTM FIA Meter Plus (FS-114)

FinecareTM FIA Meter III Plus (FS-205)

Immunofluorescence Quantitative Test System● FinecareTM Platform

FinecareTM Automatic (FS-301)

Benefits and Advantages: ● Reliable Fast and Accurate, Result in 3-15 mins, Full Traceability, QC Available ● Cost-efficient Full Test Line, CE/CFDA/FSC/NGSP/IFCC Certified, Competitive Price ● Easy-to-use LCD Touch Screen, Multi-lingual, Interal Thermal Printer, Built-in Temperature Control ● Room Temperature Stable Test Kit Store at 2-30℃, 24 Months Expiry Period ● Date Management and Transmission HIS/LIS Connectivity

FinecareTM FIA Meter serise is a fluorescence immunochromatographic analysing system which can help diagnose conditions such as infection, diabetes, cardiovascular diseases, renal injury and cancers, etc.The FinecareTM platform provides reliable and quantitative results of various kinds of analytes in human blood or urine within several minutes.Application: Laboratory, ER, Cardiology, ICU, Respiratory, Pediatrics, etc.

*Ongoing

Immunofluorescence Quantitative Test System FS-112/FS-113/FS-114/FS-205

CategoryCat. No. Test Item DiseasesSpecimen

TypeReaction

TimeSampleVolume

MeasuringRange Qualification

Coagulation

Craniocerebral Injury Markers

D-Dimer Thrombosis

Thrombosis

WB/Plasma

WB/Plasma

5 min 0.1-10 mg/L

S/P/WBTumor Markers

AFP Liver Cancer 15 min 5-400 ng/mL

PSA Prostate Cancer S/P/WB

S/P/WB

15 min 2-100 ng/mL

CEA Cancer 15 min 1-500 ng/mL

S/P/WBfPSA Prostate Cancer 15 min 0.2-30 ng/mL CE

S/P/WB

Diabetic & Renal Injury Markers

HbA1c Diabetes Mellitus Whole Blood 5 min 4.0-14.5%

MAU Renal Injury Urine 3 min 5-300 mg/L

CysC Renal Injury 5 min 0.2-10 mg/L

S/P/WB CE

CE IFCC NGSP

Renal Injury Urine 15 min 10-1500 ng/mL

Proximal RenalTubule Dysfunction 10 min 0.3-20 mg/L

NGAL

β2-MG

S/P/WB

S/P/WB

S/P/WB

S/P/WB

S/P/WB

S/P/WBCardiac Markers

NT-proBNP Heart Failure

Heart Failure

15 min 18-35000 pg/mL

cTn I MyocardialInfarction

MyocardialInfarction




15 min 0.1-50 ng/mL

Myo 15 min 2.0-400 ng/mL

CK-MB 15 min 0.3-100 ng/mL

H-FABP 15 min 1-120 ng/mL

5-5000 pg/mL

3 in 1(cTn I/Myo/CK-MB) 15 min Same with

single items

S/P/WB

S/P/WB CE

CE

CE

CE

0.1-10 mg/L CE


CVD

BNP

hsCRP

15 min

2 in 1(cTn I/ NT-proBNP) 15 min

3 min

Same withsingle items

0.1mg/L-10mg/L

InflammationMarkers

PCT Sepsis S/P/WB

S/P/WB

S/P/WB

15 min

15 min

0.1-100 ng/mL

1.0-300 mg/L CE

CE

CE

CE

CRP(hsCRP+CRP) Inflammation

Infection & Inflammation

S/P/WB 15 minInfection & Inflammation

3 min 0.5-200 mg/L

CRP:0.5-150 mg/LPCT:0.1-100 ng/L

SAA

2 in 1(CRP+PCT)

S/P/WB

Fertility

Fertility 15 min 2-200,000 mIU/mLβ-HCG

S/P/WBFertility 15 min 1-100 mIU/mLLH

S/P/WBFertility 15 min 1-100 mIU/mLFSH

S/P/WB CE

CE

CE

CE

CE

CE

CE

CE

CE

CE

Fertility 15 min 1.5-60 ng/mLProg

S/P/WB

S/P/WB

S/P/WB

Fertility

Fertility

Fertility

15 min

15 min

15 min

S/P/WBFertility 15 min

1-200 ng/mL

9-3000 pg/mL

0.2-15 ng/mL

0.1-16 ng/mL

PRL

E2

Testosterone

AMH

S/P/WB

S/P/WB

S/P/WB CE

CE

CET3 0.61-9.22 nmol/L

12.87-300 nmol/L

0.1-100 mIU/L

T4

TSH

fT3

15 min

15 min

15 min

15 min 0.40-50.00 pmol/L or 0.26~32.55 ng/dL

Thyroid Function

Cortisol Cortisol disorders 15 minS/P/WB 50 nmol/L~1000 nmol/LOthers

Plasma/Serum 5-100 ng/mLVitamin D 15 min

75 μL

S100β Cerebral IschemiaCerebral Hemorrhage 15 min 0.05-10 ng/mL75 μL

75 μL

75 μL

75 μL

75 μL

10 μL

75 μL

10 μL

75 μL

10 μL

75 μL

75 μL

75 μL

75 μL

75 μL

75 μL

75 μL

75 μL

10 μL

50/75 μL

75 μL

10 μL

3-4000 pg/mLS/P/WB 15 minInflammationIL-6 75 μL

5/8.5 μL

20 μL

75 μL

75 μL

75 μL

75 μL

75 μL

75 μL

75 μL

75 μL

75 μL

75 μL

75 μL

75 μL

75 μL

75 μLBone MetabolismVitamin

CE

CE

CE

CE

Qualitative10 min10 μL CE

CE

CE

CE

0123

0123

fT41.00~100 pmol/L or 0.078~7.77 ng/dL

Thyroid Malfunction

Thyroid Malfunction

Thyroid Malfunction

Thyroid Malfunction

Thyroid Malfunction

S/P/WB

S/P/WB 15 min

Ongoing: Ferritin, FOB, H.Pylori antigen, Vit-B12, ST2

CE

CE

One step D-Dimer

TnT

S/P/WB

S/P/WB 15 min

15 min

100 μL for whole blood75 μL for plasma/serum

100 μL for whole blood75 μL for plasma/serum

0.03-10 ng/mLMyocardialInfarction

Atherosis

CE

W276 S/P/WBSARS-CoV-2 Ab COVID-19

Qualitative10 min10 μL CEW277 S/P/WBSARS-CoV-2 IgMCOVID-19

COVID-19

W241

W207

W206

W219

W228

W229

W231

W232

W220

W200

W259

W225

W244

W245

W233

W246

W247

W248

W866

W202

W203

W204

W205

W217

W216

W222

W223

W240

W254

W242

W239

W211

W227

W210

W201

W218

W251

W221

W208

W209

W226

W230

W250

Lp-PLA2 S/P/WB

S/P/WB

75 μL 15 min 10-1000 ng/mL

OUR VISIONProvide professional products and services of rapid diagnosis and chronic disease management; Pursue

better and convenient user experience; Promote high-standard life and health quality; Fulfill shared dream

of our staff, customers and partners.

1,500+ Employees

200+ R&D Staffs

2 Overseas Lab

1 Branch

10+ Overseas Offices

Guangzhou

Chicago Branch

Jakarta Manila

Belo Horizonte

Delhi

San Diego Lab

Nairobi

Abuja

Cape Town

Istanbul

Cairo

Guangzhou Wondfo Biotech Co., Ltd.

No. 8 Lizhishan Road, Science City, Luogang District, 510663, Guangzhou, P.R. China

Tel: +86-20-32296083Fax: +86-20-32296063E-mail: [email protected]: www.en.wondfo.com.cn

Customers Service Center:Tel: +86-20-32296083Fax: +86-20-32296063E-mail: [email protected]

Rev. A6 Rel.: 2020/03/24

材质：封面157克双铜过哑膜内页80克双铜+骑马钉

尺寸规格：210*285mm

申请人：

物料编码及项目名称：41000812 国际产品目录2020

颜色：四色设计师：许广添

设计时间： 2020.03.24

new poct solution · sales of rapid diagnostic reagents and related equipment in ivd (in vitro...

Documents