OYP

Anti-Jcv Antibody Detection Assay

Product code

OYP

Device name

Anti-Jcv Antibody Detection Assay

Device class

Class 2

21 CFR

21 CFR 866.3336

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).