Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm
Medical specialty
Microbiology
Device class
2
Regulation number
866.3510
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.