FDA product code OEM

Human Metapneumovirus (Hmpv) Rna Assay System

Microbiology·Class 2·21 CFR 866.3980
US regulatory classifications
US Product Code (FDA)
OEM
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 866.3980
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Medical specialty
Microbiology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hmpv) rna extracted from human respiratory specimens or viral cultures. Detection of hmpv rna aids in the diagnosis of respiratory hmpv infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infections.

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About this record

Human Metapneumovirus (Hmpv) Rna Assay System 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.