Panels › Microbiology › Product code OEM · Class 2
Human Metapneumovirus (Hmpv) Rna Assay System
Regulation 866.3980
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OEM
| Company | 510(k)s | Recalls |
|---|---|---|
| Quidel Corp. | 3 | 0 |
| Gen-Probe Prodesse, Inc. | 2 | 0 |
| Prodesse, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 2023 | K230349 | Lyra RSV+hMPV Assay Quidel Corporation | OEM |
| Aug 14, 2013 | K132200 | PRO HMPV+ ASSAY Gen-Probe Prodesse, Inc. | OEM |
| Mar 8, 2013 | K122189 | QUIDEL MOLECULAR RSV + HMPV ASSAY Quidel Corp. | OEM |
| Jan 16, 2013 | K123838 | PRO HMPV+ ASSAY Gen-Probe Prodesse, Inc. | OEM |
| Dec 15, 2011 | K112490 | QUIDEL MOLECULAR HMPV ASSAY Quidel Corp. | OEM |
| Nov 7, 2008 | K082688 | PRO HMPV+ ASSAY Prodesse, Inc. | OEM |
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