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

FDA product code PUQ · 1 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3510
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-05-19 – 2017-05-19

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.

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