Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
Microbiology · 21 CFR 866.3510
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 MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
1 recall events for this product code
Registered firms
3 firms currently registered for this product code
510(k) clearances
3 clearances for this product code
- Dynex Technologies, Inc.Sep 29, 2023
K212769 · DYNEX SmartPLEX MMRV IgG Assay Kit
- Bio-Rad LaboratoriesAug 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 LaboratoriesMar 29, 2010
K091616 · BIOPLEX 2200 MMRV IGG