Device |
multiplex flow immunoassay, t. gondii, rubella and cmv |
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. |
Product Code | OMI |
Regulation Number |
866.3510
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Device Class |
2
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