FDA 510(k) Applications for Medical Device Product Code: QEP ()

FDA 510(k) Applications for Medical Device Product Code "QEP"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K222379	Abbott Molecular Inc.	Alinity m STI Assay	03/03/2023
K202977	Abbott Molecular, Inc.	Alinity m STI Assay	04/29/2022
K210585	Becton Dickinson and Company	BD CTGCTV2	05/10/2022
K200533	binx health Inc	binx io CT/NG Assay and binx io CT/NG System	04/27/2020
K191352	binx health, Inc.	binx health io CT/NG Assay	08/08/2019
K190441	Cepheid	Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit	05/23/2019
K220321	Hologic, Inc.	Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris	06/03/2022
K190515	Hologic, Inc.	Aptima Combo 2 Assay (Panther System)	05/23/2019
K200866	Hologic, Inc.	Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)	05/17/2020
K200436	Hologic, Inc.	Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit	03/23/2020
DEN180047	Hologic, Inc.	Aptima Mycoplasma genitalium Assay	01/23/2019
K193081	Rheonix, Inc	Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit	12/17/2021
K202408	Roche Molecular Systems, Inc.	cobas CTNG for use on cobas 6800/8800 systems	01/21/2021
K190433	Roche Molecular Systems, Inc.	cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit	05/22/2019
K200748	Visby Medical	Visby Medical Sexual Health	08/26/2021
K220407	Visby Medical	Visby Medical Sexual Health Test	03/07/2023