FDA product code OPL

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

Microbiology·Class 2·21 CFR 866.3510
US regulatory classifications
US Product Code (FDA)
OPL
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3510
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Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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.

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About this record

Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus is a medical device type in the Microbiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.