OPL — Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus Class II
FDA product code OPL covers "Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus", a Class II medical device regulated under 21 CFR 866.3510. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
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 |