Specification Sheet
Product Name Fetal Bovine Serum,
non-USA origin, from USDA approved countries, Heat Inactivated, sterile-filtered, suitable for cell culture
Product Number 12306C
Product Brand SIGMA
 
TEST SPECIFICATION
Sterility No microbial growth detected (USP)
Mycoplasma None detected (Broth Culture)
Osmolality 260 - 330 mOsm/kg H2O
AVA (9CFR113.53) Bovine Adenovirus - Record
  Bovine Parvovirus - Record
  Blue Tongue Virus - Record
  Bovine Virus Diarrhea - Record
  Cytopathic Effect - Record
  Hemadsorption - Record
  Infectious Bovine Rhinotracheitis -,Record
  Parainfluenza 3 - Record
  Rabies Virus - Record
  Reovirus - Record
  Bovine Respiratory Syncytial Virus -,Record
  Vesicular Stomatitis Virus - Record
Location of Reserve Sample Present
Total Protein 3.0 - 4.5 g/dL
Tetracycline Tetracycline - Record
Virus Antibody Test BRSV BRSV - Record titer
Virus Antibody Test BVD BVD - Record titer
Virus Antibody Test IBR IBR - Record titer
Virus Antibody Test PI3 PI3 - Record titer
Cloning Efficiency Tested
Electrophoretic Profile A/G ratio - Record
  Albumin (g/dL) - Record
  Alpha 1 Globulin (g/dL) - Record
  Alpha 2 Globulin (g/dL) - Record
  Beta Globulin (g/dL) - Record
  Gamma Globulin (g/dL) - Record
Mycoplasma None detected (DNA Fluorochrome Stain)
Plating Efficiency Tested
pH 6.8 - 8.1
Bovine IgG (mcg/mL) - Record
Ouchterlony Test Satisfactory (reaction to species of,origin only)
Endotoxin <= 10.0 EU/mL
Growth Promotion/Cytotoxicity Tested
Hemoglobin Test <= 25 mg/dL
Safety Testing Satisfactory
Country of Origin Record Country of Origin
Appearance Clear, light straw-dark amber liquid
   
COMMENTS
   
Intended Use For Research or Further Manufacturing Uses Only.
  NOT INTENDED FOR DIRECT USE IN HUMANS OR ANIMALS.
Storage -10 to -40 C
Extended Item Desc. Fetal Bovine Serum
  Heat Inactivated
  for 30 minutes at 56 C
Origin This material is sourced from government approved abattoirs from the
  country listed above. The animals receive ante- and post- mortem
  veterinary inspection and are deemed fit for human consumption.
C of A comments For imported material, USDA safety testing results are provided if
  required.
  Data on this Certificate of Analysis is generated from pre-heat
  inactivated material.
Misc. Refer to item master labels for label format. Item master labels are on
  file at site of manufacture.
Label Requirements Not For Animal or Human Consumption
  Date of Manufacture: N Expiration Date: Y
  Date of Expiration Format DDMMMYY
  Heat Inactivation Date Format MMMYY
Expiration Notes for FG Expiration Date: 60 months from date of manufacture
  Stop Lot Date: 58 months from date of manufacture
Misc. Recording AVA results:
  If all viruses are none detected, report as none detected.
  If all viruses but BVD are none detected (positive for BVD only), report
  as tested.
  If any virus other than BVD is detected, report as detected for that virus
  and none detected for the other viruses.
Control Comments 12103/12107/13107
Misc. *NVSL Safety Testing is required only if lot is imported into the U.S.
Specification 12306C.00000008
Approval Date 12/18/2017