HyClone Laboratories, Inc.
 

 

Characterized Fetal Bovine Serum, US Origin, EMEA Conforming

Characterized Fetal Bovine Serum, US Origin,
EMEA/CVMP/743/00 and CPMP/BWP/1793/02 Conforming
SH30532.02 100 mL
SH30532.03 500 mL

Characterized FBS is comparable to the highest quality FBS from other suppliers. It is lower in price than Defined FBS, but meets the requirements of most discriminating FBS users. Characterized FBS is filtered through three sequential 100nm (0.1 µm) pore-size rated 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 Phosphorus, Osmolality, Iron, Total Iron Binding Capacity (TIBC), Percent Saturation, Glucose, and IgG.

Tests for SH30532 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 per EP
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 per EP
Large Volume, Direct Culture Not Detected
Hoechst DNA Stain Not Detected
Bovine Viral Diarrhea Virus
Antibodies Not Detected
Interference/Comparative Titration Not Detected
Gamma Irradiation >30 kGy
(>3.0 Mrad)
Post-Irradiation Testing - BVDV
Antibodies Pass
Interference/Comparative Titration No Interference
Quantitation Not Detected
Certificate of Suitability Included


Characterized Fetal Bovine Serum, US Origin, EMEA/CPMP/BWP/1793/02 Conforming
SH30071.02 100 mL
SH30071.03 500 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.

Tests for SH30071 (EMEA/CPMP) 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
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
Fetal Bovine Serum
  - US Defined
  - US Characterized
  - US Standard
  - Certified Australian
  - Standard Australian
  - New Zealand
  - USDA Tested
  - Research Grade EU Approved
  - US Defined EMEA Conforming
  - US Characterized EMEA Conforming
  - Australian EMEA Conforming
  - New Zealand EMEA Conforming
Specialty FBS
Bovine Calf Serum
Fetal Bovine Replacement
Other Serum
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