OMI — Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv Class II
FDA product code OMI covers "Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv", a Class II medical device regulated under 21 CFR 866.3510. Submissions are reviewed by the Microbiology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OMI
- Device Class
- Class II
- Regulation Number
- 866.3510
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.