HyClone Laboratories, Inc.
 

 

Defined Iron-Supplemented Bovine Calf Serum, US Origin, EMEA Conforming

Defined Iron-Supplemented Bovine Calf Serum, US Origin, EMEA Conforming
SH30534.02 100 mL
SH30534.03 500 mL
SH30534.04 1000 mL

Defined Iron-Supplemented Bovine Calf Serum is collected by venipuncture from formula-fed veal calves, which produce exceptionally high levels of transferrin. We carefully supplement this serum with iron to load serum transferrin levels to physiological levels. After supplementation, our Iron-Supplemented Bovine Calf Serum contains three to four times as much available iron and transferrin as FBS or equine serum. Many researchers have found this product to be an excellent and cost-effective alternative to FBS. Growth promotion studies have demonstrated the many applications of Iron-Supplemented Bovine Calf Serum and show that it often out per forms FBS in many applications. As with all our calf serum products, this product is sterile filtered using three sequential 100 nm (0.1 µm) pore-size rated filters..

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 EMEA Labeled Products Specification
Endotoxin (Limulus Amebocyte Lysate - Gel Clot) <10 EU/mL
Hemoglobin (spectophotometric) <10 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


Defined Iron-Supplemented Bovine Calf Serum, US Origin, EMEA Conforming
SH30072.02 100 mL
SH30072.03 500 mL
SH30072.04 1000 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) <10 EU/mL
Hemoglobin (spectophotometric) <10 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