FDA Product Code OEM: Human Metapneumovirus (hmpv) Rna Assay System
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.
Leading manufacturers include Quidel Corporation.
List of Human Metapneumovirus (hmpv) Rna Assay System devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Human Metapneumovirus (hmpv) Rna Assay System devices (product code OEM). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →