FDA Product Code
FDA Product Code OUY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.3860
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K231316 | Aptima Trichomonas vaginalis Assay | Hologic, Inc. | 2023-11-06 | Traditional | PDF ↗ |
| K182692 | BD MAX CTGCTV2, BD MAX System | Becton, Dickinson and Company | 2019-01-08 | Traditional | PDF ↗ |
| K151589 | BD MAX CT/GC/TV, BD MAX INSTRUMENT | Becton, Dickinson and Company | 2016-09-06 | Traditional | PDF ↗ |
| K161619 | Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems | Cepheid | 2016-08-29 | Traditional | PDF ↗ |
| K161182 | Solana Trichomonas Assay | Quidel Corporation | 2016-08-15 | Traditional | PDF ↗ |
| K151565 | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit | Cepheid | 2015-10-16 | Traditional | PDF ↗ |
| K143329 | AmpliVue Trichomonas Assay | Quidel Corporation | 2015-03-17 | Traditional | PDF ↗ |
| K130268 | BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2013-08-23 | Traditional | PDF ↗ |
| K122062 | APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER | Gen-Probe, Inc. | 2013-01-09 | Traditional | PDF ↗ |
| DEN110012 | APTIMA TRICHOMONAS VAGINALIS ASSAY | Gen-Probe Incorporated | 2011-04-19 | Post-NSE | — |
Product code OUY · Class II · Immunology. Data: openFDA.