What is FDA product code QEP?

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.

Immunology & Microbiology › Serological ReagentsNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections

Cobas® TV/MG

Name: cobas® TV/MG
Brand: cobas® TV/MG

cobas TV/MG is an automated qualitative PCR test for detecting Trichomonas vaginalis and Mycoplasma genitalium DNA on cobas 6800/8800 systems. Supported specimens include urine, vaginal and…

Registry build 21.09.26

cobas TV/MG is an automated qualitative PCR test for detecting Trichomonas vaginalis and Mycoplasma genitalium DNA on cobas 6800/8800 systems. Supported specimens include urine, vaginal and endocervical samples in cobas PCR Media, with organism-specific additional specimen types.

Automated processing extracts nucleic acids using magnetic glass particles before amplification. An internal DNA control monitors preparation and PCR, while positive and negative external controls are processed with each run.

Specimen and Result Scope

Cervical PreservCyt specimens support TV detection, and meatal swabs support MG detection. The system reports positive, negative or invalid results. Specimen collection follows the specified clinical-setting and collector requirements.

1manufacturer

2catalogue numbers in this listing

7510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code QEP
Manufacturer	City	Province	Registered as	Device types
Hochuen Medical Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	20

Record

Regulatory record for cobas® TV/MG
Listed by	Roche Molecular Systems, Inc., United States
FDA product code	QEP
Device type	Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Device class	Class 2
Regulation	21 CFR 866.3393
Establishment	Specification developer, Manufacturer, Exporter
510(k)	K190433
Record published	2026-02-24

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for cobas® TV/MG
Catalogue number	Size	Status
08017450190		In distribution
09040633190		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Aptima	Hologic, Inc.	5
Alinity m	Abbott Molecular, Inc.	4
Xpert CT/NG	Cepheid	2
Aptima Combo 2®	Hologic, Inc.	2
cobas® TV/MG Positive Control Kit	Roche Molecular Systems, Inc.	2
binx io	Binx Health, Ltd.	1
Visby Medical Men’s Sexual Health Test	Visby Medical, Inc.	1
BD COR CTGCTV2 US	Becton, Dickinson AND Company	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K260917	2026-07-08
K253756	2026-05-15
K253759	2026-05-15
K240217	2025-01-17
K240197	2025-01-16
K202408	2021-01-21
K190433	2019-05-22

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.