OEM
6 FDA 510(k) clearances · Product code
53 daysmedian time to decision
227 days90th percentile
6clearances measured
FDA profile
- Official device name
- Human Metapneumovirus (Hmpv) Rna Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Medical specialty
- Microbiology
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| Lyra RSV+hMPV Assay (K230349) | Quidel Corporation | 2023-03-10 | + Add |
| PRO HMPV+ ASSAY (K132200) | Gen-Probe Prodesse, Inc. | 2013-08-14 | + Add |
| QUIDEL MOLECULAR RSV + HMPV ASSAY (K122189) | Quidel Corp. | 2013-03-08 | + Add |
| PRO HMPV+ ASSAY (K123838) | Gen-Probe Prodesse, Inc. | 2013-01-16 | + Add |
| QUIDEL MOLECULAR HMPV ASSAY (K112490) | Quidel Corp. | 2011-12-15 | + Add |
| PRO HMPV+ ASSAY (K082688) | Prodesse, Inc. | 2008-11-07 | + Add |
Track OEM automatically
Every clearance here is in the API, with alerts when new ones post.