OEM — Human Metapneumovirus (Hmpv) Rna Assay System Class II
FDA product code OEM covers "Human Metapneumovirus (Hmpv) Rna Assay System", a Class II medical device regulated under 21 CFR 866.3980. Submissions are reviewed by the Microbiology panel. At least 6 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K230349 | quidel corporation | Lyra RSV+hMPV Assay | March 10, 2023 |
| K132200 | gen-probe prodesse | PRO HMPV+ ASSAY | August 14, 2013 |
| K122189 | quidel | QUIDEL MOLECULAR RSV + HMPV ASSAY | March 8, 2013 |
| K123838 | gen-probe prodesse | PRO HMPV+ ASSAY | January 16, 2013 |
| K112490 | quidel | QUIDEL MOLECULAR HMPV ASSAY | December 15, 2011 |
| K082688 | prodesse | PRO HMPV+ ASSAY | November 7, 2008 |