OEM

Human Metapneumovirus (Hmpv) Rna Assay System

Product code

OEM

Device name

Human Metapneumovirus (Hmpv) Rna Assay System

Device class

Class 2

21 CFR

21 CFR 866.3980

Medical specialty

Microbiology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

6 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).