Product code OYP

Device name

Anti-Jcv Antibody Detection Assay

Medical specialty

Microbiology

Device class

2

Regulation number

866.3336

Review panel

MI

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

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.

Source

FDA openFDA device classification dataset