510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OMIClass II

Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv

21 CFR 866.3510 / Microbiology
FDA source (opens on fda.gov)

OMI is the FDA product code for Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv, a class II device type, regulated under 21 CFR 866.3510. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OMI
Device name
Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
FDA 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.
Regulation
21 CFR 866.3510
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code OMI

By decision year
2 clearances under product code OMI with a decision year between 2009 and 2012, 2009 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OMI by decision year
YearClearances
20091
20121

Applicants with the most clearances

Product code OMI
Applicants holding the most 510(k) clearances under product code OMI
ApplicantClearances
Bio-Rad Laboratories Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code