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.

Alinity M · Nucleic Acid Detection System for Non-Viral Microorganism(S) Causing Sexually Transmitted Infections → Immunology & Microbiology

Name: Alinity m
Brand: Alinity m

1manufacturer

4catalogue numbers in this listing

2510(k) clearances naming this product code

1recall

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 Alinity m
Listed by	Abbott Molecular, 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)	K202977
Record published	2022-05-19
Record revised	2025-05-21 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Alinity m
Catalogue number	Size	Status
09N17-095		In distribution
09N18-001		In distribution
09N17-085		In distribution
09N17-03A		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Aptima	Hologic, Inc.	5
Xpert CT/NG	Cepheid	2
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
K222379	2023-03-03
K202977	2022-04-29

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Alinity m
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Abbott Molecular, Inc.	UDI-DI	2024-09-12	Class II	Device Design	Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced	15068 units

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.

Alinity M