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Human Metapneumovirus (Hmpv) Rna Assay System

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.

Global Registration Data
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Human Metapneumovirus (Hmpv) Rna Assay System
Microbiology Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

OEM

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Class 2

21 CFR 866.3980

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Microbiology

Device Characteristics

No

No

No

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.