Atlas FDA

QEP

24 FDA 510(k) clearances · Product code

171 daysmedian time to decision
521 days90th percentile
24clearances measured

FDA profile

Official device name
Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3393
Medical specialty
Microbiology
FDA definition
A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data.
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RecordFirmDate
cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems (K260917)Roche Molecular Systems, Inc.2026-07-08
cobas liat CT/NG/MG nucleic acid test (K253759)Roche Molecular Systems, Inc.2026-05-15
cobas liat CT/NG nucleic acid test (K253756)Roche Molecular Systems, Inc.2026-05-15
Visby Medical Men's Sexual Health Test (K251501)Visby Medical, Inc.2025-10-01
BD CTGCTV2 (K243343)Bd Integrated Diagnostic Solutions/Becton,2025-04-22
cobas® liat CT/NG nucleic acid test (K240217)Roche Molecular Systems, Inc.2025-01-17
cobas® liat CT/NG/MG nucleic acid test (K240197)Roche Molecular Systems, Inc.2025-01-16
NeuMoDx CT/NG Assay 2.0 (K230267)Neumodx Molecular, Inc.2023-12-22
Visby Medical Sexual Health Test (K220407)Visby Medical2023-03-07
Alinity m STI Assay (K222379)Abbott Molecular, Inc.2023-03-03
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 (K220321)Hologic, Inc.2022-06-03
BD CTGCTV2 (K210585)Becton, Dickinson and Company2022-05-10
Alinity m STI Assay (K202977)Abbott Molecular, Inc.2022-04-29
Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit (K193081)Rheonix, Inc.2021-12-17
Visby Medical Sexual Health (K200748)Visby Medical2021-08-26
cobas CTNG for use on cobas 6800/8800 systems (K202408)Roche Molecular Systems, Inc.2021-01-21
Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) (K200866)Hologic, Inc.2020-05-17
binx io CT/NG Assay and binx io CT/NG System (K200533)Binx Health, Inc.2020-04-27
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 (K200436)Hologic, Inc.2020-03-23
binx health io CT/NG Assay (K191352)Binx Health, Inc.2019-08-08
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 (K190441)Cepheid2019-05-23
Aptima Combo 2 Assay (Panther System) (K190515)Hologic, Inc.2019-05-23
cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit (K190433)Roche Molecular Systems, Inc.2019-05-22
Aptima Mycoplasma genitalium Assay (DEN180047)Hologic, Inc.2019-01-23

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Every clearance here is in the API, with alerts when new ones post.