Regulatory Requirement Testing for USDA/APHIS 9th Code of Federal Regulation 113.5 including 113.46, and 113.47 final analysis.

Assay ID----------Description of Assay
9C-113.53----------USDA/APHIS 9CFR compliance testing by 113.53c requirement for products of animal origin.
9C-113.55----------USDA/APHIS 9CFR compliance testing by 113.55 requirement for MSV viral material
9C-113.52----------USDA/APHIS 9CFR compliance testing by 113.52 requirement for Cell Lines used for Production of Biologics
9C-113.51----------USDA/APHIS 9CFR compliance testing by 113.51 requirement for Primary Cells used for Production of Biologics
 
Modified Individual Virus Testing using procedures outlined in USDA/APHIS 9th Code of Federal Regulation 113.5 including 113.47 specific virus FA final analysis. For individual virus investigation only.

Assay ID-----------Description of Assay
9CM-113.53-------Modified Individual Virus Testing using procedures outlined in USDA/APHIS 9 CFR 113.53c for products of animal origin. Does not satisfy full 113.53c requirements.
9CM-113.55-------Modified Individual Virus Testing using procedures outlined in USDA/APHIS 9CFR 113.55 for MSV viral material. Does not satisfy full 113.55 requirements.
9CM-113.52-------Modified Individual Virus Testing using procedures outlined in USDA/APHIS 9CFR 113.52 requirement for Cell Lines used for Production of Biologics. Does not satisfy full 113.52 requirement.
9CM-113.51-------Modified Individual Virus Testing using procedures outlined in USDA/APHIS 9CFR 113.51 requirement for Primary Cells used for Production of Biologics. Does not satisfy full 113.51 requirement.

Modified Individual Virus Testing using specialized cell lines and or media requirements following procedures outlined in USDA/APHIS 9th Code of Federal Regulation 113.53c including 113.47 specific virus FA final analysis. For individual virus investigation only.

Assay ID Description of Assay
9CM-113.53-V,8----Modified Individual Virus Testing using procedures outlined in USDA/APHIS 9CFR compliance testing by 113.53c requirement for products of animal origin. Assay uses MA-104 host cells and specialized growth media for detection of Rotavirus. Does not satisfy full 113.53c requirements.
9CM-113.53-V,11---Modified Individual Virus Testing using procedures outlined in USDA/APHIS 9CFR compliance testing by 113.53c requirement for products of animal origin. Assay uses porcine fibroblast host cells and specialized growth media for detection of PCMV. Does not satisfy full 113.53c requirements.
9CM-113.53-P,9-----Modified Individual Virus Testing using procedures outlined in USDA/APHIS 9CFR compliance testing by 113.53c requirement for products of animal origin. Assay uses MA-104 host cells and specialized growth media for detection of PCMV. Does not satisfy full 113.53c requirements.

Species currently testing: Bovine, Porcine, Equine, Caprine, Ovine, Canine, Feline, and Murine

We provide 9/CFR Regulatory Compliance Testing but we can custom taylor Modified Testing to fit your needs.

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