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

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.

Global Registration Data
Multi-Country Intelligence
Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OPL

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Class 2

21 CFR 866.3510

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Microbiology

Device Characteristics

No

No

No

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 patientยฟs serological status to measles virus, mumps virus, Rubella and VZV. The test is not intended for use in screening blood or plasma donors.