Mycoplasma Testing

OVERVIEW:
Regulatory compliance mycoplasma assays to satisfy various regulations,including USDA-APHIS 9 CFR, European Pharmacopeia (EP), and United States Pharmacopeia (USP). Additionally, Mycoplasma testing of large volumes by Barile's direct culture method &
MATERIALS TESTED:
Animal Origin Products​
Cell Lines
Virus Seeds
SPECIES:

BOVINE

CAMELID

CANINE

CAPRINE

CERVINE

EQUINE

FELINE

MURINE

OVINE

PORCINE
FULL DESCRIPTION:
VMRD offers mycoplasma assays to satisfy various regulations, including:
- USDA-APHIS 9CFR (9CFR 113.53a and 113.28)
- European Pharmacopeia (EP), European Medicinal Agency (EMA) (EP 2.6.7, EMA)
- United States Pharmacopeia (USP <63>)
Additionally:
- Large Volume Barile method mycoplasma detection assay (broth and agar method)
- Large Volume Barile method mycoplasma detection assay (indirect culture on indicator cells)
AVAILABLE TESTS
-
Assay ID
9C-MY-IN
-
Materials
Tested Serum,powder,cell lines/stocks,virus banks/lots -
Regulations
Satisfied *9CFR 113.52c,113.53a -
Samples
Required 10 ml/1 g/6 x 1 ml aliquots - Turnaround 31-38
-
Assay ID
9C-MY
-
Materials
Tested Serum,powder,cell lines/stocks,virus banks/lots -
Regulations
Satisfied 9CFR 113.52c,113.53a -
Samples
Required 10 ml/1 g/2 x 1 ml aliquots - Turnaround 31-38
-
Assay ID
EPUSP-MY-DIR
-
Materials
Tested Serum,powder,cell lines/stocks,virus banks/lots -
Regulations
Satisfied EP 2.6.7, USP 63 -
Samples
Required 35 ml/5 g/35 X 1 ml aliquots - Turnaround 31-38
-
Assay ID
EPUSP-MY-IND
-
Materials
Tested Serum,powder,cell lines/stocks,virus banks/lots -
Regulations
Satisfied EP 2.6.7 and USP 63 -
Samples
Required 5 ml/1 g/5 X 1 ml aliquots - Turnaround 14-21
-
Assay ID
EPUSP-MY-IN-DIR
-
Materials
Tested Serum,powder,cell lines/stocks,virus banks/lots -
Regulations
Satisfied EP 2.6.7 and USP 63 -
Samples
Required 75 ml/5 g/75 X 1 ml aliquots - Turnaround 31-38
-
Assay ID
EPUSP-MY-IN-IND
-
Materials
Tested Serum,powder,cell lines/stocks,virus banks/lots -
Regulations
Satisfied EP 2.6.7 and USP 63 -
Samples
Required 10 ml/1 g/10 X 1 ml aliquots - Turnaround 31-38
-
Assay ID
LVB-MY-B&A
-
Materials
Tested Serum products -
Regulations
Satisfied N/A -
Samples
Required 100ml/10g - Turnaround 28
-
Assay ID
LVB-MY-IND
-
Materials
Tested Serum products -
Regulations
Satisfied N/A -
Samples
Required 100ml/10g - Turnaround 14
Contact Us
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