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

Binx Io

Name: binx io
Brand: binx io

The binx io CT/NG cartridge contains reagents for detecting Chlamydia trachomatis and Neisseria gonorrhoeae DNA with the binx io instrument. It uses female vaginal swabs collected in a…

Registry build 21.09.26

The binx io CT/NG cartridge contains reagents for detecting Chlamydia trachomatis and Neisseria gonorrhoeae DNA with the binx io instrument. It uses female vaginal swabs collected in a clinical setting or male urine specimens to aid diagnosis in symptomatic or asymptomatic patients.

Within the cartridge, sample preparation releases and purifies DNA, PCR amplifies target sequences, and electrochemical detection identifies the amplified material. The instrument controls fluid movement through cartridge valves and reports a qualitative result.

Listed Item

binx io CT/NG cartridge

Process Control

An internal process control passes through extraction, amplification and detection with the specimen and checks the validity of negative results. A symptomatic male patient with a negative chlamydia result should receive further testing with a laboratory molecular test.

1manufacturer

1catalogue number

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 binx io
Listed by	Binx Health, Ltd., United Kingdom
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	Manufacturer
510(k)	K200533
Record published	2025-09-03

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Packaging	Shipper of 50

Catalogue Numbers

Catalogue numbers for binx io
Catalogue number	Size	Status
V1 (CT/NG)		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
Aptima Combo 2®	Hologic, Inc.	2
cobas® TV/MG Positive Control Kit	Roche Molecular Systems, Inc.	2
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
K200533	2020-04-27
K191352	2019-08-08

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of binx io
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Binx Health, Ltd.	510(k) number	2023-03-29	Class II	Under Investigation by firm	May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce either false negative CT or positive CT results	50 single-use cartridges

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.