DeviceClearance

Product code OPL— Microbiology

BIOPLEX 2200 MMRV IGG

Classification name
Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
Device class
Class 2
Regulation
21 CFR 866.3510
Advisory panel
Microbiology
Total cleared
3
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OPL under 21 CFR 866.3510, via openFDA

Market context for product code OPL

FDA has cleared 3 devices under product code OPL between 2010 and 2023, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OPL

Recent clearances under product code OPL

Data sourced from openFDA. This site is unofficial and independent of the FDA.