FDA Product Code OPL: Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
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.
Leading manufacturers include Bio-Rad Laboratories and Dynex Technologies, Inc..
3
Total
3
Cleared
395d
Avg days
2010
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus Devices (Product Code OPL)
3 devices
Cleared
Sep 29, 2023
DYNEX SmartPLEX MMRV IgG Assay Kit
Dynex Technologies, Inc.
Microbiology
759d
Cleared
Aug 23, 2011
BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL
Bio-Rad Laboratories
Microbiology
127d
Cleared
Mar 29, 2010
BIOPLEX 2200 MMRV IGG
Bio-Rad Laboratories
Microbiology
299d
About Product Code OPL - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code OPL since 2010, with 3 receiving FDA clearance (average review time: 395 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.