FDA.reportPublic FDA data

Aptima®

Primary DI
15420045505766
Brand
Aptima®
Company
Hologic, Inc.
Model
KIT, CONTROLS, ATV, 250 CE
Catalog number
302807
Device description
Aptima® Trichomonas vaginalis Controls Kit.
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
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
K200436000

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
K200436000Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kitHologic, Inc.2020-03-23QEP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045505766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550576615420045505766

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 Temperature2 Degrees Celsius8 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