Trichomonas Vaginalis Nucleic Acid Amplification Test System
Immunology · 21 CFR 866.3860
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 MDR events
30 adverse event reports on file
- HPVJul 31, 2026InjuryHologic, Inc.2024800-2026-00056
- APTIMA TRICHOMONAS VAGINALIS NUCLEIC ACID ASSAYJun 5, 2026InjuryHologic, Inc.2024800-2026-00028
- APTIMA TRICHOMONAS VAGINALIS ASSAY; APTIMA TRICHOMONAS VAGINALIS CONTROLS KITMar 13, 2026InjuryHologic, Inc.2024800-2026-00013
- APTIMA TRICHOMONAS VAGINALISNov 6, 2024InjuryHologic, Inc.2024800-2024-00034
- BD MAX¿ CT/GC/TVMar 14, 2023MalfunctionGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2023-00009
- BD MOLECULAR SWAB COLLECTION KITMar 2, 2023MalfunctionBecton, Dickinson & Co. (sparks)1119779-2023-00201
- BD MOLECULAR SWAB COLLECTION KITFeb 24, 2023MalfunctionBecton, Dickinson & Co. (sparks)1119779-2023-00169
- BD CTGCTV2 FOR BD MAX¿ SYSTEM (US)Dec 28, 2022MalfunctionGeneohm Sciences Canada, Inc. (bd Diagnostics)3007420875-2022-00082
- BD MAX¿ CT/GC/TVDec 19, 2022MalfunctionBecton, Dickinson & Co. (sparks)1119779-2022-01510
- BD MAX¿ CT/GC/TVDec 19, 2022MalfunctionBecton, Dickinson & Co. (sparks)1119779-2022-01512
Event type breakdown
Recalls
4 recall events for this product code
- GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
2 in 1 Trichomonas / Gardnerella Test
Distribution without premarket approval/clearance.
Z-0816-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
3 in 1 STI Test
Distribution without premarket approval/clearance.
Z-0817-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
8 in 1 STI Test Kit
Distribution without premarket approval/clearance.
Z-0818-2026 · View FDA record ↗ - Becton Dickinson & Co.TerminatedUnknown
Kit BD Max CT/GC/TV;
The foil bags containing extraction tubes for BD MAX" Reagent products may not been sealed properly.
Z-2331-2019 · View FDA record ↗
Registered firms
34 firms currently registered for this product code
Becton, Dickinson & Co.
SPARKS, MD, US
Abbott Molecular, Inc.
Des Plaines, IL, US
Hologic, Inc.
SAN DIEGO, CA, US
Diagnostic Automation/ Cortez Diagnostics Inc,.
Woodland Hills, CA, US
Cepheid
Lodi, CA, US
Abbott Molecular Distribution Center
Itasca, IL, US
Roche Molecular Systems, Inc.
Branchburg, NJ, US
Cepheid
Sunnyvale, CA, US
Ortho-clinical Diagnostics, Inc.
ATHENS, OH, US
Visby Medical, Inc.
San Jose, CA, US
Geneohm Sciences Canada, Ulc.
Quebec, CA
Diamond Diagnostics Inc.
Budapest, HU
510(k) clearances
10 clearances for this product code
- Hologic, Inc.Nov 6, 2023
K231316 · Aptima Trichomonas vaginalis Assay
- Becton, Dickinson and CompanyJan 8, 2019
K182692 · BD MAX CTGCTV2, BD MAX System
- Becton, Dickinson and CompanySep 6, 2016
K151589 · BD MAX CT/GC/TV, BD MAX INSTRUMENT
- CepheidAug 29, 2016
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
- Quidel CorporationAug 15, 2016
K161182 · Solana Trichomonas Assay
- CepheidOct 16, 2015
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
- Quidel CorporationMar 17, 2015
K143329 · AmpliVue Trichomonas Assay
- Becton, Dickinson & COAug 23, 2013
K130268 · BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY