Who else makes this device?

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

Immunology & Microbiology › Serological ReagentsDna Probe, Nucleic Acid Amplification, Chlamydia

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 urogenital disease using the Tigris® DTS® Automated Analyzer or semi-automated instrumentation as specified.

1manufacturer

4catalogue numbers in this listing

1510(k) clearance

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 MKZ
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	MKZ
Device type	Dna Probe, Nucleic Acid Amplification, Chlamydia
Device class	Class 1
Regulation	21 CFR 866.3120
Establishment	Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k)	K060652
Record published	2016-03-11
Record revised	2024-07-22 (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 15 to 30 °C
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Aptima Combo 2®
Catalogue number	Size	Status
KIT,APT. COMBO 2 (ROOM TEMP)CE		In distribution
KIT,APTIMA COMBO 2,100T,RT,CEIVD-UPDATED		In distribution
KIT,APTIMA COMBO 2,250T,RT,CEIVD-UPDATED		In distribution
KIT,APTIMA COMBO 2 (REFRIG) CE		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Aptima®	Hologic, Inc.	7
Alinity m	Abbott Molecular, Inc.	2
Multi-Collect	Abbott Molecular, Inc.	1
cobas z 480	Roche Molecular Systems, Inc.	1
BD ProbeTec™ Chlamydia trachomatis Qx Assay Gray Amp Reagent Pack	Becton, Dickinson AND Company	1
BD Molecular Swab Sample Buffer Tubes	Becton, Dickinson AND Company	1
cobas&#x00AE PCR Media Uni Swab Sample Kit	Roche Molecular Systems, Inc.	1
BD Molecular LBC Sample Buffer Tubes	Becton, Dickinson AND Company	1
cobas Ctng Qualitative nucleic acid test for use on the cobas 6800/8800 Systems	Roche Molecular Systems, Inc.	1
Progensa	Hologic, Inc.	1
BD CTGCTV2	Becton, Dickinson AND Company	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K230451	2023-11-16

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.