Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER

K-Number: K122062 · 2013-01-09

ApplicantGen-Probe, Inc.
Decision Date2013-01-09
Product CodeOUY
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER is the device name listed in this FDA 510(k) record. The listed applicant is Gen-Probe, Inc.. It received FDA 510(k) clearance on 2013-01-09 under 510(k) number K122062. The device is classified under product code OUY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER?

APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER is a medical device that received FDA 510(k) clearance on 2013-01-09. The listed applicant is Gen-Probe, Inc.. The 510(k) number is K122062.

When did APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER receive FDA 510(k) clearance?

APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER received FDA 510(k) clearance on 2013-01-09, under 510(k) number K122062.

Who is the listed applicant for APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER?

The FDA 510(k) record lists Gen-Probe, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER?

The FDA product code for APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER is OUY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Gen-Probe, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K111409APTIMA COMBO 2 ASSAYK063664GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091K063451GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199K062440GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091K061413APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEMK061509TIGRIS DTS GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1196

View all 62 devices →

Related Devices (Code: OUY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231316Aptima Trichomonas vaginalis AssayHologic, Inc.K182692BD MAX CTGCTV2, BD MAX SystemBecton, Dickinson and CompanyK151589BD MAX CT/GC/TV, BD MAX INSTRUMENTBecton, Dickinson and CompanyK161619Xpert 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 SystemsCepheidK161182Solana Trichomonas AssayQuidel CorporationK130268BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAYBecton, Dickinson & CO

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑