Who else makes this device?

Name: Aptima
Brand: Aptima

Immunology & Microbiology › Serological ReagentsDna-Reagents, Neisseria

Aptima

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

Registry build 21.09.26

Aptima® GC assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® Neisseria gonorrhoeae assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection of ribosomal RNA (rRNA) from Neisseria gonorrhoeae (GC) to aid in the diagnosis of gonococcal urogenital disease using the Tigris® DTS® System or semi-automated instrumentation as specified.

1manufacturer

11catalogue 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
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)	K200436
Record published	2022-07-28
Record revised	2024-08-28 (version 8)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C
Distribution end date	2018-03-08
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Aptima
Catalogue number	Per pack	Status
AC2, REFRIG, 250T, READY MADE		In distribution
KIT, AUTO DETECT, APTIMA, AS		In distribution
KIT, BOX 1, REF, AGC, 100-T, AS, IVD		In distribution
APTIMA GC ASSAY FLUIDS		In distribution
KIT, BOX 2, RT, AGC 100-T, AS, IVD		In distribution
KIT, AC2 SYS FL PRES,TIG,IVD-CE (302380)		In distribution
KIT, AC2 ASSAY FL, TIG, IVD-CE (302382)		In distribution
APTIMA GC ASSAY SPECIFIC REAGENTS		In distribution
APTIMA CONTROLS KIT, IVD		In distribution
APTIMA AUTO DETECT KIT (CE)		In distribution
APTIMA VAGINAL SWAB COLLECTION KIT	50	Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
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
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.