Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm

PUQ · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3510

Classification

FDA Product Code: PUQ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.3510
Review panel: MI
Medical specialty: Microbiology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

The kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii (T. gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 2

Source

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