Panels › Microbiology › Product code OPL · Class 2
Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
Regulation 866.3510
0510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in OPL
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio-Rad Laboratories | 2 | 0 |
| Cell Marque Corporation | 0 | 1 |
| Dynex Technologies, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 29, 2023 | K212769 | DYNEX SmartPLEX MMRV IgG Assay Kit Dynex Technologies, Inc. | OPL |
| Aug 23, 2011 | K111072 | BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL Bio-Rad Laboratories | OPL |
| Mar 29, 2010 | K091616 | BIOPLEX 2200 MMRV IGG Bio-Rad Laboratories | OPL |
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