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Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv

FDA product code OMI · 2 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
2009-02-23 – 2012-03-26

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.

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