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.
6
Total
6
Cleared
80d
Avg days
2008
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Human Metapneumovirus (hmpv) Rna Assay System Devices (Product Code OEM)
6 devices
About Product Code OEM - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code OEM since 2008, with 6 receiving FDA clearance (average review time: 80 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.