Panels › Microbiology › Product code OQO · Class 2
Herpes Simplex Virus Nucleic Acid Amplification Assay
Regulation 866.3305
0510(k)s in 12 months (12 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OQO
| Company | 510(k)s | Recalls |
|---|---|---|
| Eragen Biosciences | 2 | 0 |
| Becton, Dickinson & CO | 1 | 0 |
| Biohelix Corporation | 1 | 0 |
| DiaSorin Molecular LLC | 0 | 1 |
| Focus Diagnostics | 1 | 0 |
| Hologic, Inc. | 1 | 0 |
| Intelligent Medical Devices, Inc. | 1 | 0 |
| Qiagen | 1 | 0 |
| Quidel Corporation | 1 | 0 |
| Roche Molecular Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 1, 2018 | K172509 | Sentosa SA201 HSV 1/2 Qualitative PCR Test Vela Diagnostics USA, Inc. | OQO |
| Jun 15, 2017 | K162673 | Aptima Herpes Simplex Viruses 1 & 2 Assay Hologic, Inc. | OQO |
| Aug 28, 2015 | K150962 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack Focus Diagnostics | OQO |
| Jun 1, 2015 | K150617 | cobas HSV 1 and 2 Test Roche Molecular Systems, Inc. | OQO |
| Feb 13, 2015 | K142156 | SEEGENE ANYPLEX II HSV-1/2 ASSAY Seegene | OQO |
| Dec 19, 2014 | K142738 | artus HSV-1/2 QS-RGQ MDx Kit Qiagen | OQO |
| May 13, 2014 | K140198 | IMDX HSV-1/2 FOR ABBOTT M2000 Intelligent Medical Devices, Inc. | OQO |
| Mar 26, 2014 | K140029 | AMIPLIVUE HSV 1&2 ASSAY Quidel Corporation | OQO |
| Sep 27, 2011 | K111951 | ISOAMP HSV ASSAY Biohelix Corporation | OQO |
| Aug 3, 2011 | K111527 | MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT Eragen Biosciences, Inc. | OQO |
| Mar 18, 2011 | K103798 | BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS Becton, Dickinson & CO | OQO |
| May 12, 2010 | K100336 | MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711 Eragen Biosciences | OQO |
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