use official - nucleus biologicsthe country of origin of the animals is australia. the serum was...

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CERTIFICATE OF ANALYSIS Not For Official Use

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Page 1: Use Official - Nucleus BiologicsThe country of origin of the animals is Australia. The serum was aseptically processed and filter steril-ized in Australia

CertifiCate of analysis

Not For

Official

Use

Page 2: Use Official - Nucleus BiologicsThe country of origin of the animals is Australia. The serum was aseptically processed and filter steril-ized in Australia

COA-2

GENERAL/STERILITYTEST METHOD RESULTS SPECIFICATIONHemoglobin UV/Vis Spectrophotometer ≤ 15 mg/dLEndotoxin Kinetic Turbidmetric ≤4 EUmLVisual examination Visual Satisfactory

Specificity Species I.D. BovineSterility Millipore Steritest - Broth

CultureSterile

Mycoplasma Broth Culture 35 day Incuba-tion

Not Detected

VIRUSES (9CFR 113-53C) RESULTS SPEC.Bovine Respiratory Syncytial Virus N.D.

Bovine Viral Diarrhea Virus N.D.

Bovine Parvovirus N.D.

Bluetongue Virus N.D.

Bovine Adenovirus N.D.

Rabies Virus N.D.Reovirus (Fluorescent Antibody) N.D.Infectious Bovine Rhinotracheitis (IBR) (Cytopathic Agents)

N.D.

Para Influenza 3 (PI3) (Hemadsorbing Agents)

N.D.

EMEA:CHMP/BWP7.3.2 Test for specified viruses7.3.3 BVDV7.3.4 Virus Neutralization Index

BVD Virus Type 1BVD Virus Type 2

N.D.N.D.A.R.

HORMONE METHOD RESULTS SPEC.Insulin EIA A.R.Progesterone EIA A.R.Estradiol EIA A.R.Testosterone EIA A.R.Thyroxine (T4) EIA A.R.Triiodothy-ronine (T3)

EIA A.R.

Cortisol EIA A.R.

A.R. = As ReportedN.D. = Not Detected

VIRAL SCREENHORMONE PANEL

STATEMENT OF ORIGINThis serum was derived from blood aseptically collected in an approved abattoir (single) in Australia. The country of origin of the animals is Australia. The serum was aseptically processed and filter steril-ized in Australia.

Product Fetal Bovine Serum - Sterile FilteredProduct Reference Number FBS1824-001Country of Origin AustraliaCertificate of Suitability On fileLot NumberFiltration Triple 0.1 MicronManufacture DateExpiration Date

Not For

Official

Use

Page 3: Use Official - Nucleus BiologicsThe country of origin of the animals is Australia. The serum was aseptically processed and filter steril-ized in Australia

COA-3

ANTIBODY METHOD RESULTS SPEC.BVD VNT A.R.IBR VNT A.R.PI3 ELISA A.R.BT ELISA A.R.Akabane ELISA A.R.EBL ELISA A.R.

A.R. = As ReportedN.D. = Not Detected

ANTIBIOTIC RESULTS SPEC.(Method: Liquid Chromatography - Mass Spectrometry - lower limit of detection 25.55 ng/mL)Chlortetracyline A.R.

Doxytetracyline A.R.

Oxytetracyine A.R.

Tetracyline A.R.

TEST METHOD RESULTS SPEC.pH 6.9-7.6

Osmolality Osmometer 280-365 mOsmol/kg

Total Protein Beckman Coulter Synchron Clinical Systems

3.0-4.5 g/dL

Albumin Electrophoresis A.R.Total Globulins

α1 Globulin β1 Globulinβ2 Globulinγ Globulin

Electrophoresis A.R.

Electrophoresis Pattern

Agarose Gel Plate

Typical

IgG ELISA ≤400 μg/mL

BIOLOGICAL PROFILE ANTIBODY PROFILE

SUBSTANCE RESULTS SPEC.(Method: Beckman DXC 800 Analyzer)

Sodium A.R.

Potassium A.R.

Chloride A.R.

Bicarbonate A.R.

Anion Gap A.R.

Glucose A.R.

Urea A.R.

Creatinine A.R.

Urea/Creatinine A.R.

Urate A.R.

Bilirubin total A.R.

Calcium A.R.

Phosphate A.R.

Alkaline Phosphatase A.R.

Gamma Glutamyl Transferase A.R.

Alanine Transaminase: (GPT) A.R.

Aspartate Transaminase: (GOT) A.R.

Lactate Dehydrogenase A.R.

Triglyceride A.R.

Iron A.R.

Iron Binding Capacity A.R.

Transferrin A.R.

Ferritin (Method: EIA) A.R.

Cholesterol

HDL LDL (Calculated) VLDL (Calculated)

≤1.2 mmol/LA.R.A.R.A.R.

BIOCHEMICAL PROFILE

FUNCTIONAL ASSAYS

TETRACYLINE SCREEN

S. SandersNucleus Quality Department

Date:

P. Shadle, PhDQuality Control Department

Date:

Not For

Official

Use

Page 4: Use Official - Nucleus BiologicsThe country of origin of the animals is Australia. The serum was aseptically processed and filter steril-ized in Australia

COA-4

[email protected]

For a digital copy, please visit https://www.nucleusbiologics.com

For a copy of the MSDS, please visit https://www.nucleusbiologics.com

Not For

Official

Use