PUQ

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

Product code

PUQ

Device name

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

Device class

Class 2

21 CFR

21 CFR 866.3510

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

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