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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device human metapneumovirus (hmpv) rna assay system
Regulation Description Respiratory viral panel multiplex nucleic acid assay.
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.
Product CodeOEM
Regulation Number 866.3980
Device Class 2

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