HyClone Laboratories, Inc.
 

 

HyClone Sera: Donor Adult Bovine Serum, US Origin, EMEA Conforming

Donor Adult Bovine Serum, US Origin, EMEA Conforming
SH30527.02 100 mL
SH30527.03 500 mL

Donor Adult Bovine serum (ABS) is sourced in the USA, from a closed herd maintained on USDA licensed premises. Cattle from these closed herds are used exclusively for the production of donor bovine blood products. They receive regular veterinary inspections and care. Prior to entering the herd, the cattle are quarantined for 30 days and are tested for tuberculosis, brucellosis, and bluetongue virus. Donor Adult Bovine Serum is sterile filtered using three sequential 100 nm (0.1 µm) pore-size filters

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

Tests for EMEA Labeled Products Specification
Endotoxin (Limulus Amebocyte Lysate - Gel Clot) <50 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


Donor Adult Bovine Serum, US Origin, EMEA Conforming
SH30075.02 100 mL
SH30075.03 500 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.

Test Specification
Endotoxin (Limulus Amebocyte Lysate - Gel Clot) <50 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

Products Section Navigation
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
Copyright © 2008
Thermo Fisher Scientific Inc.
 
Learn more about Thermo Scientific Life Science Research Products
RNAi Technologies Nucleic Acid Amplification Protein Research High Content Screening In Europe