OUY — Trichomonas Vaginalis Nucleic Acid Amplification Test System Class II
FDA product code OUY covers "Trichomonas Vaginalis Nucleic Acid Amplification Test System", a Class II medical device regulated under 21 CFR 866.3860. Submissions are reviewed by the Immunology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OUY
- Device Class
- Class II
- Regulation Number
- 866.3860
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Immunology
- Implant
- No
Definition
In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K231316 | hologic | Aptima Trichomonas vaginalis Assay | November 6, 2023 |
| K182692 | becton, dickinson and | BD MAX CTGCTV2, BD MAX System | January 8, 2019 |
| K151589 | becton, dickinson and | BD MAX CT/GC/TV, BD MAX INSTRUMENT | September 6, 2016 |
| K161619 | cepheid | Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II | August 29, 2016 |
| K161182 | quidel corporation | Solana Trichomonas Assay | August 15, 2016 |
| K151565 | cepheid | Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneX | October 16, 2015 |
| K143329 | quidel corporation | AmpliVue Trichomonas Assay | March 17, 2015 |
| K130268 | becton, dickinson and | BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY | August 23, 2013 |
| K122062 | gen-probe | APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER | January 9, 2013 |
| DEN110012 | gen-probe incorporated | APTIMA TRICHOMONAS VAGINALIS ASSAY | April 19, 2011 |