Panels › Microbiology › Product code OOU · Class 2
Parainfluenza Multiplex Nucleic Acid Assay
Regulation 866.3980
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in OOU
| Company | 510(k)s | Recalls |
|---|---|---|
| Hologic, Inc. | 2 | 0 |
| Gen-Probe Prodesse, Inc. | 1 | 0 |
| Prodesse, Inc. | 1 | 0 |
| Quidel Corporation | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 23, 2017 | K172282 | Panther Fusion Paraflu Assay Hologic, Inc. | OOU |
| Dec 9, 2015 | K153223 | ProParaFlu+ Assay Hologic, Inc. | OOU |
| Oct 9, 2014 | K141927 | LYRA PARAINFLUENZA VIRUS ASSAY Quidel Corporation | OOU |
| Aug 26, 2013 | K132238 | PROPARAFLU+ ASSAY Gen-Probe Prodesse, Inc. | OOU |
| Nov 20, 2009 | K091053 | PROPARAFLU+ASSAY Prodesse, Inc. | OOU |
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