FDA.reportPublic FDA data

Aptima Combo 2®

Primary DI
15420045505704
Brand
Aptima Combo 2®
Company
Hologic, Inc.
Model
KIT, APTIMA COMBO 2, TIGRIS ROOM TEMP (IVD) CE
Catalog number
302305
Device description
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.
Published
2016-04-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LSLDNA-REAGENTS, NEISSERIA
MKZDNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSLDna-Reagents, NeisseriaMicrobiology2
MKZDna Probe, Nucleic Acid Amplification, ChlamydiaMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060652000
K132251000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060652000TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAYGen-Probe, Inc.2006-08-17LSL
K132251000APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)Hologic / Gen-Probe Incorporated2013-10-17LSL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045505704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550570415420045505704

GMDN Terms#

Term, Definition table
TermDefinition
Multiple sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
050579217
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25420045516691RESPDIRECT™RESPDIRECT COLLECTION KIT, US-KIT, BOXPRD-077882023-08-14
00850346007030CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
00850346007047CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
00850346007061CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
00850346007092CoolSeal™ RevealCSL-RV105-10CSL-RV105-102021-05-19
00850346007085CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
15420045500372ProcleixUltrio Plus 1K3025732014-08-06
15420045500389ProcleixUltrio Plus 1K3025732014-08-06
15420045500396ProcleixUltrio Plus 1K3025732014-08-06
15420045500402ProcleixUltrio Plus 1K3025732014-08-06
15420045500419ProcleixUltrio Plus 5K3025742014-08-06
15420045500426ProcleixUltrio Plus 5K3025742014-08-06
15420045500433ProcleixUltrio Plus 5K3025742014-08-06
15420045500440ProcleixUltrio Plus 5K3025742014-08-06
15420045500457ProcleixUltrio Plus 5K3025742014-08-06
15420045500464ProcleixUltrio Plus, HIV-1 D-Probes3025712014-08-06
15420045500471ProcleixUltrio Plus HBV D-Probes3025762014-08-06
15420045500488ProcleixUltrio Plus HCV D-Probes3025772014-08-06
15420045500495ProcleixUltrio Plus TIGRIS Controls3025722014-08-06
15420045500501ProcleixUltrio Plus Calibrators3025752014-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00875197007251cobas® liat CT, NG and MG control kitRoche Molecular Systems, Inc.LSL2026-02-24
00875197007268cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.LSL2026-02-24
00875197007275cobas® liat CT/NGRoche Molecular Systems, Inc.LSL2026-02-24
00382904439248BD Molecular Urine Transport KitBECTON, DICKINSON AND COMPANYMKZ2024-05-16
00382904439248BD Molecular Urine Transport KitBECTON, DICKINSON AND COMPANYLSL2024-05-16
30382904402960BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-26
30382904402960BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYLSL2024-02-26
00382904402969BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-26
30382904439232BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-23
30382904439232BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYLSL2024-02-23
00382904439231BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-23
15420045511880Aptima®Hologic, Inc.MKZ2023-10-26
15420045511880Aptima®Hologic, Inc.LSL2023-10-26
00884999051096Alinity mABBOTT MOLECULAR INC.LSL2023-09-14
00884999051096Alinity mABBOTT MOLECULAR INC.MKZ2023-09-14
00810031720064Visby Medical Sexual Health TestVisby Medical, Inc.LSL2023-04-19
00810031720064Visby Medical Sexual Health TestVisby Medical, Inc.MKZ2023-04-19
10810031720061Visby Medical Sexual Health TestVisby Medical, Inc.LSL2023-04-19
00810031720071Visby Medical Power Adapter, Right AngleVisby Medical, Inc.LSL2023-04-19
00810031720071Visby Medical Power Adapter, Right AngleVisby Medical, Inc.MKZ2023-04-19
15420045514966APTIMAHologic, Inc.MKZ2022-07-28
15420045514966APTIMAHologic, Inc.LSL2022-07-28
15420045514973APTIMAHologic, Inc.MKZ2022-07-28
15420045514973APTIMAHologic, Inc.LSL2022-07-28
00382904439040BD CTGCTV2 for BD MAX™ SystemBECTON, DICKINSON AND COMPANYMKZ2022-07-14
00382904439040BD CTGCTV2 for BD MAX™ SystemBECTON, DICKINSON AND COMPANYLSL2022-07-14
00382904439897BD COR™ MXBECTON, DICKINSON AND COMPANYMKZ2022-06-16
00382904439897BD COR™ MXBECTON, DICKINSON AND COMPANYLSL2022-06-16
00382904439798BD CTGCTV2BECTON, DICKINSON AND COMPANYLSL2022-06-08
00382904439798BD CTGCTV2BECTON, DICKINSON AND COMPANYMKZ2022-06-08