Who else makes this device?

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

Immunology & Microbiology › Serological ReagentsDna-Reagents, Neisseria

Aptima Combo 2®

Aptima Combo 2® Assay, 250 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, 250 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 urogenital disease using the Tigris® DTS® Automated Analyzer or semi-automated instrumentation as specified.

1manufacturer

4catalogue numbers in this listing

2510(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 LSL
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	LSL
Device type	Dna-Reagents, Neisseria
Device class	Class 2
Regulation	21 CFR 866.3390
Establishment	Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k)	K060652
Record published	2020-06-16
Record revised	2023-11-08 (version 5)

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,APTIMACOMBO2,100T,REF,CEIVD-UPDATED		In distribution
KIT, APTIMA COMBO 2, TIGRIS ROOM TEMP (IVD) CE		In distribution
KIT, BX 1 (REFRIG) AC2, 100T, AS, IVD		In distribution
KIT APTIMA COMBO 2 TIGRIS-REF (IVD)-CE		In distribution

Same Product Code

Other products under the same FDA product code
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RealTime	Abbott Molecular, Inc.	3
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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
Alinity m	Abbott Molecular, Inc.	1

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K231329	2024-01-26
K180681	2018-06-13

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.