Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
The Multiplex Flow Immunoassay for T. Gondii, Rubella, and CMV (product code OMI) is a Class 2 in vitro diagnostic device regulated under 21 CFR 866.3510 in the Microbiology specialty (MI), cleared via 510(k). It is intended for the quantitative detection of IgG antibodies to Toxoplasma gondii and Rubella, and the qualitative detection of CMV IgG in human serum or plasma, to aid in determining serological status to these pathogens; it is not intended for screening blood or plasma donors. The device is not an implant or life-sustaining.
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Basic Information
- Product Code
- OMI
- Device Class
- FDA class 2
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.