OMIClass II

Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv

Microbiology · 21 CFR 866.3510

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.

MDR events24All time

Recalls1All time

Registered firms3Currently listed

510(k) clearances2All time

Recent MDR events

24 adverse event reports on file

Event type breakdown

Malfunction24

Most-reported manufacturers

Abbott Manufacturing, Inc.9 Abbott Manufacturing Inc7 Beckman Coulter Inc.3 Beckman Coulter, Inc.1 Roche Diagnostics1 Siemens Healthcare Diagnostics Inc.1 Tosoh Hi-tec Inc.1 Tosoh Hi-tec, Inc.,1

Recalls

1 recall events for this product code

BioCheck Inc
TerminatedMar 11, 2011
CVM IgG ELISA kit ;
Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
Z-1638-2011 · View FDA record ↗

Registered firms

3 firms currently registered for this product code

510(k) clearances

2 clearances for this product code