Panels › Immunology › Product code OUY · Class 2
Trichomonas Vaginalis Nucleic Acid Amplification Test System
Regulation 866.3860
0510(k)s in 12 months (10 all time)
3recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in OUY
| Company | 510(k)s | Recalls |
|---|---|---|
| GET TESTED INTERNATIONAL AB | 0 | 3 |
| Becton, Dickinson & CO | 1 | 1 |
| Becton, Dickinson and Company | 2 | 0 |
| Cepheid | 2 | 0 |
| Gen-Probe Incorporated | 2 | 0 |
| Quidel Corporation | 2 | 0 |
| Hologic, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 6, 2023 | K231316 | Aptima Trichomonas vaginalis Assay Hologic, Inc. | OUY |
| Jan 8, 2019 | K182692 | BD MAX CTGCTV2, BD MAX System Becton, Dickinson and Company | OUY |
| Sep 6, 2016 | K151589 | BD MAX CT/GC/TV, BD MAX INSTRUMENT Becton, Dickinson and Company | OUY |
| Aug 29, 2016 | K161619 | Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Cepheid | OUY |
| Aug 15, 2016 | K161182 | Solana Trichomonas Assay Quidel Corporation | OUY |
| Oct 16, 2015 | K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s Cepheid | OUY |
| Mar 17, 2015 | K143329 | AmpliVue Trichomonas Assay Quidel Corporation | OUY |
| Aug 23, 2013 | K130268 | BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY Becton, Dickinson & CO | OUY |
| Jan 9, 2013 | K122062 | APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER Gen-Probe, Inc. | OUY |
| Apr 19, 2011 | DEN110012 | APTIMA TRICHOMONAS VAGINALIS ASSAY Gen-Probe Incorporated | OUY |
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