Anti-Jcv Antibody Detection Assay

OYP · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3336

Classification

FDA Product Code: OYP
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3336
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown