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OEM — Human Metapneumovirus (Hmpv) Rna Assay System Class II

FDA Device Classification

Classification Details

Product Code
OEM
Device Class
Class II
Regulation Number
866.3980
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K230349quidel corporationLyra RSV+hMPV AssayMarch 10, 2023
K132200gen-probe prodessePRO HMPV+ ASSAYAugust 14, 2013
K122189quidelQUIDEL MOLECULAR RSV + HMPV ASSAYMarch 8, 2013
K123838gen-probe prodessePRO HMPV+ ASSAYJanuary 16, 2013
K112490quidelQUIDEL MOLECULAR HMPV ASSAYDecember 15, 2011
K082688prodessePRO HMPV+ ASSAYNovember 7, 2008