HyClone Laboratories, Inc.
 

 

Newborn Calf Serum, New Zealand Origin, EMEA Conforming

Newborn Calf Serum, New Zealand Origin, EMEA/CVMP/743/00 and CPMP/BWP/1793/02 Conforming
SH30560.01 500 mL
SH30560.02 1000 mL

As with our New Zealand FBS products, all New Zealand calf sera products are carefully collected, processed, and filtered in New Zealand and offer maximum safety against bovine diseases. We follow the same standards in processing our calf serum as with our FBS to ensure the highest quality and absolute traceability.

Assays (subject to change without notice): Gamma Globulin, Alkaline Phosphatase, Lactate Dehydrogenase, Glutamic Pyruvic Transaminase (SGPT), Glutamic Oxaloacetic Transaminase (SGOT), Total Protein, Albumin, Blood Urea Nitrogen, Creatinine, Total Bilirubin, Sodium, Potassium, Calcium, Chloride, Inorganic Phosphorous, Glucose, pH, Osmolality, Iron, Total Iron Binding Capacity (TIBC), Percent Saturation, and IgG.

Tests for SH30560 Specification
Endotoxin (Limulus Amebocyte Lysate - Gel Clot) <100 EU/mL
Hemoglobin (spectophotometric) <50 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


Newborn Calf Serum, New Zealand Origin, EMEA/CPMP/BWP/1793/02 Conforming
SH30401.01 100 mL
SH30401.02 500 mL
SH30401.03 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.

Tests for SH30401 (EMEA/CPMP) Specification
Endotoxin (Limulus Amebocyte Lysate - Gel Clot) <100 EU/mL
Hemoglobin (spectophotometric) <50 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

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Fetal Bovine Serum
Specialty FBS
Bovine Calf Serum
  - Defined
  - Defined, Iron Supplemented
  - Bovine Growth Serum(BGS)
  - Cosmic Calf
  - Newborn
  - New Zealand Defined
  - New Zealand Defined Iron Supplemented
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  - New Zealand Newborn
  - New Zealand Newborn Iron Supplemented
  - Defined EMEA Conforming
  - Defined, Iron-Supplemented EMEA Conforming
  - Cosmic Calf EMEA Conforming
  - New Zealand Newborn EMEA Conforming
Fetal Bovine Replacement
Other Serum
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