DeviceClearance

Product code OMI— Microbiology

BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET

Classification name
Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
Device class
Class 2
Regulation
21 CFR 866.3510
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OMI under 21 CFR 866.3510, via openFDA

Market context for product code OMI

FDA has cleared 2 devices under product code OMI between 2009 and 2012, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OMI

Recent clearances under product code OMI

Data sourced from openFDA. This site is unofficial and independent of the FDA.