Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv

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

Classification

FDA Product Code: OMI
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 immunoassay intended for the quantitative detection of IgG antibodies to Toxoplasma gondii (T. gondii) and Rubella, and qualitative detection of Cytomegalovirus (CMV) IgG in human serum and/ or plasma. Indicated as an aid in the determination of serological status to T. gondii, Rubella and CMV. This kit is not intended for use in screening blood or plasma donors.

Market data

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

Source

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