OPLClass II

Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus

21 CFR 866.3510 / Microbiology

OPL is the FDA product code for Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus, a class II device type, regulated under 21 CFR 866.3510. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 3 510(k) clearances under this code, the most recent dated 2023-09-29, and one recall.

Classification record

Product code: OPL
Device name: Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
FDA 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.
Regulation: 21 CFR 866.3510
Device class: Class II
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 3
Ingested recalls: 1

Clearances, product code OPL

By decision year

3 clearances under product code OPL with a decision year between 2010 and 2023, 2010 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OPL by decision year
Year	Clearances
2010	1
2011	1
2023	1

Applicants with the most clearances

Product code OPL

Applicants holding the most 510(k) clearances under product code OPL
Applicant	Clearances
Bio-Rad Laboratories Inc.	2
Dynex Technologies, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Bio-Rad Laboratories Inc.

Recent clearances

Product code OPL

Recent recalls

Product code OPL

Z-2208-2017Class IICell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was...Cell Marque Corporation / initiated 2017-05-05 / 1

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)