Who else makes this device?

Name: BD ProbeTec ET CT/GC Amplified DNA Assay Endocervical Collection & Transport Kit
Brand: BD ProbeTec ET CT/GC Amplified DNA Assay Endocervical Collection & Transport Kit

Immunology & Microbiology › Serological ReagentsDna-Reagents, Neisseria

BD ProbeTec ET CT/GC Amplified DNA Assay Endocervical Collection & Transport Kit

BD ProbeTec™ ET Chlamydia trachomatis and Neisseria gonorrhoeae (CT/GC) Amplified DNA Assay Endocervical Specimen Collection and DRY TRANSPORT Kit

Registry build 21.09.26

1manufacturer

1catalogue number

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 LSL
Manufacturer	City	Province	Registered as	Device types
Hochuen Medical Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	20

Record

Regulatory record for BD ProbeTec ET CT/GC Amplified DNA Assay Endocervical Collection & Transport Kit
Listed by	Becton, Dickinson AND Company, United States
FDA product code	LSL
Device type	Dna-Reagents, Neisseria
Device class	Class 2
Regulation	21 CFR 866.3390
Establishment	Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer
510(k)	K984631
Record published	2016-07-12
Record revised	2023-10-16 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 15 to 30 °C
Packaging	Shelfpack of 100
Distribution end date	2022-04-26

Catalogue Numbers

Catalogue numbers for BD ProbeTec ET CT/GC Amplified DNA Assay Endocervical Collection & Transport Kit
Catalogue number	Size	Status
440476		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Aptima	Hologic, Inc.	11
Aptima Combo 2®	Hologic, Inc.	4
RealTime	Abbott Molecular, Inc.	3
BD ProbeTec™ ET CT/GC Amplified DNA Assay Collection Kit	Becton, Dickinson AND Company	2
BD ProbeTec™ ET Diluent (CT/GC)	Becton, Dickinson AND Company	2
BD Viper™ System Remanufactured	Becton, Dickinson AND Company	1
cobas® liat CT, NG and MG control kit	Roche Molecular Systems, Inc.	1
cobas® liat CT/NG	Roche Molecular Systems, Inc.	1
BD Molecular Urine Transport Kit	Becton, Dickinson AND Company	1
BD ProbeTec™ ET Control Set	Becton, Dickinson AND Company	1
BD ProbeTec™ ET CT Reagent Pack	Becton, Dickinson AND Company	1
Visby Medical Sexual Health Click Test	Visby Medical, Inc.	1

Showing 12 of 53. All products under Dna-Reagents, Neisseria

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 BD ProbeTec ET CT/GC Amplified DNA Assay Endocervical Collection & Transport Kit
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Becton, Dickinson & Co.	510(k) number	2003-07-21	Not classified	Other	Component of in vitro diagnostic device was incorrectly installed causing incorrect reporting of patient results.	1015 units	2003-11-19

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.