Our Fetal Bovine Serum (USDA Approved) is derived from fetuses of healthy, bovine dams that have been deemed fit for human consumption through ante- and post-mortem veterinary inspection this. Manufactured utilizing current Good Manufacturing Practices (cGMP) and triple 0.1 micron filtered. Atlas Biologicals sources fetal bovine serum (USDA Approved) from countries that have met the USDA importation requirements to the United States. Approved countries must be free from exotic bovine viruses for extended periods of times. USDA maintains and updates the list on a regular basis. Blood is collected and processed in facilities registered and inspected by the competent veterinary authority by the country of origin. When foreign serum enters the country, it is quarantined in an approved USDA holding facility and representative samples are tested for exotic viruses. Upon completion of testing accompanied by negative results for the viruses in question, the serum is released and may be further processed and packaged for sale. Fetal Bovine Serum USDA origin serum has the same detailed traceability as U.S. Origin.
Countries/Products Eligible for Export to the United States
Usage Statement: For further manufacturing use. NOT FOR HUMAN OR ANIMAL CONSUMPTION
Species: 100% Bovine (Bos Taurus)
Available Product Treatments:
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 Tested for:
- 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
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 that have undergone inspection by Atlas Biologicals. All raw materials are legally imported and have passed USDA safety testing for exotic pathogens. 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-D (50 mL each) F-0500-D (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.