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Human Metapneumovirus (Hmpv) Rna Assay System

FDA product code OEM · 6 cleared devices

Class 2 Microbiology
Regulation
21 CFR 866.3980
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2008-11-07 – 2023-03-10

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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