OPL · Class II · 21 CFR 866.3510

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 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
1–3 of 3
Cleared Sep 29, 2023
DYNEX SmartPLEX MMRV IgG Assay Kit
K212769
Dynex Technologies, Inc.
Microbiology · 759d

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.

OPL devices are reviewed by the Microbiology panel. Browse all Microbiology devices →