US Origin Fetal Bovine Serum derived from fetuses of healthy, bovine dams that have been deemed fit for human consumption through ante-and post-mortem veterinary inspection. Manufactured utilizing current Good Manufacturing Practices (cGMP). Triple 0.1 micron filtered. All of our United States origin Fetal Bovine Serum is collected from slaughterhouses located within the contiguous United States that has undergone inspection by the United States Department of Agriculture (USDA). To ensure traceability, a history of quantity of material from the point of origin to final product is maintained. Atlas Biologicals produces US Origin Fetal Bovine Serum from one slaughterhouse of a specific region. When possible each bottle originates from a dedicated serum source ensuring traceability and consistency.
Usage Statement: For further manufacturing use. NOT FOR HUMAN OR ANIMAL CONSUMPTION
Species: 100% Bovine (Bos Taurus)
Serum from each facility is processed separately, reducing lot-to-lot variability. Each lot of bovine serum goes through rigorous testing using current USP, 9 CFR 113 and/or EP methods. Traceability of serum is maintained from the facility of origin to the final container.
|Test Description||Specification||Method or Reference|
|Biochemical Analysis||AS Reported||Photometric chemical analyzer|
|Endotoxin||< 10 E.U./mL||USP <85> / USP <151 LAL-Gel Clot|
|Hemoglobin||< 30 mg/mL||Spectrophotometric|
|Mycoplasma||Not Detected||Barile, M.F. and Kern, J|
|Sterility||No Growth||USP <71>, EP 2.6.1, 9CFR 113.26|
|Osmolarity||270-330 mOsm/kg||USP 785|
|Electrophoretic ID||Characteristic||Cellulose Acetate Electrophoresis|
|Total Protein||3.0-4.5||Biuret method, Doumas, Clin. Chem. Or equivalent|
|Adventitious Agents||Tested||9 CFR 113.53|
|Adventitious Agents include:|
|Blue Tongue Virus||Bovine Respiratory Syncytial Virus (bRSV)||Infectious Bovine Rhinotracheitis (IBR)|
|Bovine Adenovirus, type 1 or 3 (group A)||Bovine Viral Diarrhea Virus (BVDV)||Parainfluenza 3 (PI3)|
|Bovine Adenovirus, type 5 (group B)||Cytopathic Agents (CPE)||Rabies Virus|
|Bovine Parvovirus||Hemadsorbing Agents||Reovirus|
Atlas complies with the most recent edition of standards and wells as new standards that Quality Assurance deems appropriate. Atlas will make necessary revisions to its Quality System to ensure continued compliance with applicable standards. All documents and data prior to their issuance and use will be approved.
Conforms to applicable requirements of a quality system set forth by United States governing regulations, as well as current applicable European Commission regulations. Produced from raw materials collected from approved facilities within the contiguous United States that has undergone inspection by the United States Department of Agriculture or appropriate regulatory agency. All raw materials were collected from healthy animals having no reportable diseases have not been commingled with specified risk material as defined in the current regulation for the prevention, control and eradication of certain transmissible spongiform encephalopathies.
Catalog Number: F-0050-A (50 mL each) F-0500-A (500 mL each)
Volumes Available: 50mL and 500mL
Storage Conditions: Store at -10 to -30 degrees Celsius
Expiration Date: 5 years from the date of manufacture
Key Applications: Supports a wide variety of cell, research, and further manufacturing applications.