Chrysalis Intelligence · Product Codes · QEP

QEP · Unclassified

19 clearances · 9 unique sponsors

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Device class

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Regulation —

Total clearances

19

2020-03-23 → 2026-07-08

Last 12 months

4

Unique sponsors

9

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Roche Molecular Systems, Inc.	6	3	2026-07-08
Hologic, Inc.	3	0	2022-06-03
Visby Medical	3	1	2025-10-01
Abbott Molecular, Inc.	2	0	2023-03-03
Bd Integrated Diagnostic Solutions/Becton,	1	0	2025-04-22
Neumodx Molecular, Inc.	1	0	2023-12-22
Becton, Dickinson and Company	1	0	2022-05-10
Rheonix, Inc.	1	0	2021-12-17
Binx Health, Inc.	1	0	2020-04-27

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
87481	CPT	—	Medium	Gonorrhea/Chlamydia nucleic acid detection by TMA or SDA for STI
87661	CPT	—	Medium	Trichomonas vaginalis nucleic acid detection for STI

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-08	K260917	Roche Molecular Systems, Inc.	cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems
2026-05-15	K253759	Roche Molecular Systems, Inc.	cobas liat CT/NG/MG nucleic acid test
2026-05-15	K253756	Roche Molecular Systems, Inc.	cobas liat CT/NG nucleic acid test
2025-10-01	K251501	Visby Medical, Inc.	Visby Medical Men's Sexual Health Test
2025-04-22	K243343	Bd Integrated Diagnostic Solutions/Becton,	BD CTGCTV2
2025-01-17	K240217	Roche Molecular Systems, Inc.	cobas® liat CT/NG nucleic acid test
2025-01-16	K240197	Roche Molecular Systems, Inc.	cobas® liat CT/NG/MG nucleic acid test
2023-12-22	K230267	Neumodx Molecular, Inc.	NeuMoDx CT/NG Assay 2.0
2023-03-07	K220407	Visby Medical	Visby Medical Sexual Health Test
2023-03-03	K222379	Abbott Molecular, Inc.	Alinity m STI Assay
2022-06-03	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
2022-05-10	K210585	Becton, Dickinson and Company	BD CTGCTV2
2022-04-29	K202977	Abbott Molecular, Inc.	Alinity m STI Assay
2021-12-17	K193081	Rheonix, Inc.	Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit
2021-08-26	K200748	Visby Medical	Visby Medical Sexual Health
2021-01-21	K202408	Roche Molecular Systems, Inc.	cobas CTNG for use on cobas 6800/8800 systems
2020-05-17	K200866	Hologic, Inc.	Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
2020-04-27	K200533	Binx Health, Inc.	binx io CT/NG Assay and binx io CT/NG System
2020-03-23	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