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.

Xpert CT/NG · Nucleic Acid Detection System for Non-Viral Microorganism(S) Causing Sexually Transmitted Infections → Immunology & Microbiology

Name: Xpert CT/NG
Brand: Xpert CT/NG

1manufacturer

2catalogue numbers in this listing

1510(k) clearance

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 Xpert CT/NG
Listed by	Cepheid, 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	Contract manufacturer, Specification developer, Manufacturer, Exporter
Record published	2018-01-29
Record revised	2025-02-20 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 28 °C

Catalogue Numbers

Catalogue numbers for Xpert CT/NG
Catalogue number	Size	Status
GXCT/NG-120		In distribution
GXCT/NG-10		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
cobas® TV/MG	Roche Molecular Systems, Inc.	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
K190441	2019-05-23

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.

Xpert CT/NG