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.

Leading manufacturers include Bio-Rad Laboratories, Inc..

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
Cleared Mar 26, 2012
BIOPLEX 2200 TORC IGG
K120572
Bio-Rad Laboratories, Inc.
Microbiology · 28d
Cleared Feb 23, 2009
BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET
K080008
Bio-Rad Laboratories, Inc.
Microbiology · 418d

About Product Code OMI - Regulatory Context