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

Aptima Combo 2®

Name: Aptima Combo 2®
Brand: Aptima Combo 2®

Aptima Combo 2® Assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima Combo 2® Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro…

Registry build 21.09.26

Aptima Combo 2® Assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima Combo 2® Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal disease using the Panther® System as specified.

1manufacturer

2catalogue numbers in this listing

5510(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 Aptima Combo 2®
Listed by	Hologic, 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	Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published	2020-06-16
Record revised	2024-07-22 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
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 Aptima Combo 2®
Catalogue number	Size	Status
KIT,APTIMACOMBO2,250T,REF,CEIVD-UPDATED		In distribution
KIT, BX 2 (RT) AC2, 100T, AS, IVD		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
cobas® TV/MG	Roche Molecular Systems, 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
K220321	2022-06-03
K200866	2020-05-17
K200436	2020-03-23
K190515	2019-05-23
DEN180047	2019-01-23

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.