FDA product code OYP

Anti-Jcv Antibody Detection Assay

Microbiology·Class 2·21 CFR 866.3336
US regulatory classifications
US Product Code (FDA)
OYP
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3336
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Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

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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About this record

Anti-Jcv Antibody Detection Assay is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.