FDA.reportPublic FDA data

Aptima®

Primary DI
15420045505469
Brand
Aptima®
Company
Hologic, Inc.
Model
KIT, ATV (RT), IVD 100
Catalog number
303064
Device description
Aptima® Trichomonas vaginalis Assay, 100 test, box 2 of 2 (15°C to 30°C box). The Aptima® Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test (NAAT) for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid in the diagnosis of trichomoniasis using the Tigris® DTS® System.
Published
2016-03-23
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
OUYTrichomonas vaginalis nucleic acid amplification test system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUYTrichomonas Vaginalis Nucleic Acid Amplification Test SystemImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN110012000
K122062000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN110012000APTIMA TRICHOMONAS VAGINALIS ASSAYGen-Probe Incorporated2011-04-19OUY
K122062000APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHERGen-Probe, Inc.2013-01-09OUY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045505469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550546915420045505469

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
00382904439248BD Molecular Urine Transport KitBECTON, DICKINSON AND COMPANYOUY2024-05-16
00382904439767BD Vaginal Panel on BD COR SystemBECTON, DICKINSON AND COMPANYOUY2024-04-02
30382904402960BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYOUY2024-02-26
30382904439232BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYOUY2024-02-23
00884999051096Alinity mABBOTT MOLECULAR INC.OUY2023-09-14
00810031720064Visby Medical Sexual Health TestVisby Medical, Inc.OUY2023-04-19
00810031720071Visby Medical Power Adapter, Right AngleVisby Medical, Inc.OUY2023-04-19
15420045514980APTIMAHologic, Inc.OUY2022-07-28
15420045514997APTIMAHologic, Inc.OUY2022-07-28
15420045515000APTIMAHologic, Inc.OUY2022-07-28
15420045515017APTIMAHologic, Inc.OUY2022-07-28
00382904439040BD CTGCTV2 for BD MAX™ SystemBECTON, DICKINSON AND COMPANYOUY2022-07-14
00382904439897BD COR™ MXBECTON, DICKINSON AND COMPANYOUY2022-06-16
00382904439798BD CTGCTV2BECTON, DICKINSON AND COMPANYOUY2022-06-08
00884999048898Alinity mABBOTT MOLECULAR INC.OUY2022-05-18
00884999047686Alinity mABBOTT MOLECULAR INC.OUY2022-05-18
00884999047693Alinity mABBOTT MOLECULAR INC.OUY2022-05-18
00884999049314Alinity mABBOTT MOLECULAR INC.OUY2022-05-18
00810031720002Visby Medical Sexual Health Click TestVisby Medical, Inc.OUY2021-09-15
00810031720033Visby Medical Power AdapterVisby Medical, Inc.OUY2021-09-15
00810031720057Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 PackVisby Medical, Inc.OUY2021-09-15
07332940002954Xpert Urine Specimen Collection KitCEPHEIDOUY2018-07-02
00382904429706BD MAX™ CT/GC/TVBECTON, DICKINSON AND COMPANYOUY2018-05-25
07332940001001Xpert TVCEPHEIDOUY2018-01-29
00382904437121BD MAX™ Vaginal PanelBECTON, DICKINSON AND COMPANYOUY2017-03-23
30382904433766BD MAX™ UVE Specimen Collection KitBECTON, DICKINSON AND COMPANYOUY2016-10-17
30382904434206BD MAX™ UVE Sample Buffer TubesBECTON, DICKINSON AND COMPANYOUY2016-10-17
00382904438241BD MAX™ CT/GC/TVGeneohm Sciences Canada IncOUY2016-10-17
30014613336396SolanaQUIDEL CORPORATIONOUY2016-09-16
30014613336402SolanaQUIDEL CORPORATIONOUY2016-09-16