OPL — Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus Class II
Classification Details
- Product Code
- OPL
- Device Class
- Class II
- Regulation Number
- 866.3510
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K212769 | dynex technologies | DYNEX SmartPLEX MMRV IgG Assay Kit | September 29, 2023 |
| K111072 | bio-rad laboratories | BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX | August 23, 2011 |
| K091616 | bio-rad laboratories | BIOPLEX 2200 MMRV IGG | March 29, 2010 |