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Anti-Jcv Antibody Detection Assay

FDA product code OYP · 1 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3336
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2012-08-16 – 2012-08-16

The anti-jcv antibody detection assay is intended for the detection of antibodies to the john cunningham virus (jcv) in serum or plasma samples from multiple sclerosis (ms) and crohn's disease (cd) patients receiving immunomodulatory therapies.

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