HyClone Laboratories, Inc.
 

 

Certified Australian Foetal Bovine Serum, EMEA Conforming

Certified Australian Foetal Bovine Serum, EMEA/CPMP/BWP/1793/02 Conforming
SH30545.02 100 mL
SH30545.03 500 mL
SH30545.04 1000 mL

Our Certified Australian FBS is sourced from only USDA or AQIS (Australian Quarantine and Inspection Service) approved abattoirs in Australia. We have found that Australian methods of animal husbandry are world-class. Animal nutrition and health care are unsurpassed. As with New Zealand, Australia is an island continent thus making animal disease control and management easier than in most areas of the world. Australia is considered to be free of BSE and FMD. A comprehensive trail of paperwork ensures traceability and our Certified Australian FBS is USDA safety tested. It is sterile filtered using true pool technology through three se quen tial 100 nm (0.1 µm) pore-size rated filters.

Assays (subject to change without notice): Alkaline Phosphatase, Lactate Dehydrogenase, Glutamic Pyruvic Transaminase (SGPT), Glutamic Oxaloacetic Transaminase (SGOT), Total Protein, Albumin, Blood Urea Nitrogen, Creatinine, Total Bilirubin, Sodium, Potassium, Calcium, Chloride, Inorganic Phosphorus, Glucose, Iron, Total Iron Binding Capacity (TIBC), Percent Saturation, Gamma Globulin, Electrophoresis, IgG, pH, and Osmolality.

Tests for EMEA Labeled Products Specification
Endotoxin (Limulus Amebocyte Lysate - Gel Clot) <25 EU/mL
Hemoglobin (spectophotometric) <25 mg/dl
Sterility Testing Current USP & EP
Bacteria & Fungi No Growth
Virus Testing (9 CFR 113.53)
Flourescent Antibody
Bluetongue Not Detected
Bovine Adenovirus Not Detected
Bovine Parvovirus Not Detected
Bovine Respiratory Syncytial Virus Not Detected
Bovine Viral Diarrhea Virus Not Detected
Antibodies Pass
Interference/Comparative Titration No Interference
Quantitation Not Detected
Rabies Not Detected
Reovirus Not Detected
Bovine Leukemia Virus Not Detected
Cytopathogenic Agents - e.g IBR Not Detected
Hemadsorbing Agents - e.g. PI3 Not Detected
Mycoplasma
Large Volume, Direct Culture Not Detected
Hoechst DNA Stain Not Detected
Bovine Viral Diarrhea
Antibodies Not Detected
Interference/Comparative Titration Not Detected
Gamma Irradiation >30 kGy
(>3.0 Mrad)
Post-Irradiation Testing
Antibodies Pass
Interference/Comparative Titration No Interference
Quantitation Not Detected
Certificate of Suitability Included


Certified Australian Foetal Bovine Serum, EMEA Conforming
SH30084.02 100 mL
SH30084.03 500 mL
SH30084.04 1000 mL

HyClone recognizes the challenges in changing regulatory filings, so we also offer an option to those serum users who need to meet the human guideline requirements, but prefer to continue using the same products (no changes to the product part number) with the addition of three tests.

These products are ordered using the non-EMEA part numbers and are tested per the information below. Standard serum products that require EMEA/CPMP/ BWP/1793/02 conformance are provided with the standard Certificate of Analysis, in addition to an addendum, which includes the additional testing results. It is the combination of both documents that provide assurance that the product purchased is EMEA/CPMP/ BWP/1793/02 Conforming.

Tests Specification
Endotoxin (Limulus Amebocyte Lysate - Gel Clot) <25 EU/mL
Hemoglobin (spectophotometric) <25 mg/dl
Sterility Testing Current USP & EP
Bacteria & Fungi No Growth
Virus Testing (9 CFR 113.53)
Flourescent Antibody
Bluetongue Not Detected
Bovine Adenovirus Not Detected
Bovine Parvovirus Not Detected
Bovine Respiratory Syncytial Virus Not Detected
Bovine Viral Diarrhea Virus Not Detected
Rabies Not Detected
Reovirus Not Detected
Cytopathogenic Agents - e.g IBR Not Detected
Hemadsorbing Agents - e.g. PI3 Not Detected
Mycoplasma
Large Volume, Direct Culture Not Detected
Hoechst DNA Stain Not Detected
Certificate of Suitability Included
Additional Tests Needed to Conform to
EMEA/CPMP/BWP/1793/02
Specification
Sterility Testing (Current EP)
Bacteria & Fungi No Growth
Mycoplasma (per EP)
Large Volume, Direct Culture Not Detected
Hoechst DNA Stain Not Detected
Bovine Viral Diarrhea Virus(pre- & post- irradiation)
Interference/Comparative Titration Not Detected

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Defined FBS
Characterized FBS
Certified Australian FBS
New Zealand FBS
Defined Bovine Calf Serum
Defined Iron-Supplemented Bovine Calf Serum
Cosmic Calf
FetalClone III
Donor Adult Bovine
New Zealand Adult Bovine
New Zealand Newborn
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