OPL
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
- FDA definition
- The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to measles virus, mumps virus, Rubella and varicella zoster virus (VZV) in human serum and/ or plasma. The results of this assay are intended to be used as an aid in the assessment of a patient¿s serological status to measles virus, mumps virus, Rubella and VZV. The test is not intended for use in screening blood or plasma donors.
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| Record | Firm | Date |
|---|---|---|
| DYNEX SmartPLEX MMRV IgG Assay Kit (K212769) | Dynex Technologies, Inc. | 2023-09-29 |
| BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL (K111072) | Bio-Rad Laboratories | 2011-08-23 |
| BIOPLEX 2200 MMRV IGG (K091616) | Bio-Rad Laboratories | 2010-03-29 |
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Every clearance here is in the API, with alerts when new ones post.