OMI
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Multiplex Flow Immunoassay, T. Gondii, Rubella And Cmv
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Medical specialty
- Microbiology
- 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.
- Adverse events (MAUDE)
- 2009: 4 · 2010: 4 · 2011: 9 · 2012: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BIOPLEX 2200 TORC IGG (K120572) | Bio-Rad Laboratories, Inc. | 2012-03-26 |
| BIOPLEX 2200 SYSTEM TORC IGG KIT, CALIBRATOR SET AND CONTROL SET (K080008) | Bio-Rad Laboratories, Inc. | 2009-02-23 |
Track OMI automatically
Every clearance here is in the API, with alerts when new ones post.