OMI · Class II · 21 CFR 866.3510

FDA Product Code OMI: Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv

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.

2
Total
2
Cleared
223d
Avg days
2009
Since

FDA 510(k) Cleared Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv Devices (Product Code OMI)

2 devices
1–2 of 2
No devices found for this product code.

About Product Code OMI - Regulatory Context