OMI

Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv

Product code

OMI

Device name

Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv

Device class

Class 2

21 CFR

21 CFR 866.3510

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 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.

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