FDA.reportPublic FDA data

APTIMA

Primary DI
15420045515017
Brand
APTIMA
Company
Hologic, Inc.
Model
PANTHER,TRICH REFRIG,V2,250T,READY MADE
Catalog number
PRD-07041
Published
2022-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OUYTrichomonas vaginalis nucleic acid amplification test system
QEPNucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUYTrichomonas Vaginalis Nucleic Acid Amplification Test SystemImmunology2
QEPNucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted InfectionsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200436000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
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
15420045515017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551501715420045515017

GMDN Terms#

Term, Definition table
TermDefinition
Trichomonas vaginalis 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 the parasitic protozoan Trichomonas vaginalis in a clinical specimen, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

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
05420045503888SecurMarkSMARK-U-SS1SMARK-U-SS12015-09-04
05420045503895SecurMarkSMARK-U-SS2SMARK-U-SS22015-09-04
05420045503901SecurMarkSMARK-U-SS3SMARK-U-SS32015-09-04
15420045511859Unifi WorkspaceUnifi Workspace V1.02019-08-09
15420045515307Acessa ProVu System710071002023-05-16
15420045515314Acessa ProVu SystemMS-06-0171MS-06-01712023-05-16
15420045515284Acessa ProVu System520052002022-11-08
15420045513983BioZorbF0202F02022021-04-21
15420045513990BioZorbF0203F02032021-04-21
15420045514003BioZorbF0303F03032021-04-21
15420045514010BioZorbF0304F03042021-04-21
15420045514027BioZorbF0221F02212021-04-21
15420045514034BioZorbF0231F02312021-04-21
15420045514041BioZorbF0331F03312021-04-21
15420045514058BioZorbF0404F04042021-04-21
15420045514065BioZorbF0405F04052021-04-21
15420045512634Unifi WorkspaceUnifi Workspace V1.02020-09-21
15420045500020Selenia Dimensions C-View SoftwareC-ViewSW-030522014-09-05
15420045504561ATEC IntroducerAI090920AI0909202016-08-11
15420045504578ATEC IntroducerAI091220AI0912202016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00875197006056cobas® TV/MGRoche Molecular Systems, Inc.QEP2026-02-24
00875197006063cobas® TV/MG Positive Control KitRoche Molecular Systems, Inc.QEP2026-02-24
00875197006902cobas® TV/MGRoche Molecular Systems, Inc.QEP2026-02-24
00875197006919cobas® TV/MG Positive Control KitRoche Molecular Systems, Inc.QEP2026-02-24
00810031720125Visby Medical Men’s Sexual Health TestVisby Medical, Inc.QEP2025-10-23
00382904454357BD COR CTGCTV2 USBECTON, DICKINSON AND COMPANYQEP2025-10-21
05060441760050binx ioBINX HEALTH LIMITEDQEP2025-09-03
25060441760054binx ioBINX HEALTH LIMITEDQEP2025-09-03
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
00884999051096Alinity mABBOTT MOLECULAR INC.QEP2023-09-14
00810031720064Visby Medical Sexual Health TestVisby Medical, Inc.OUY2023-04-19
00810031720071Visby Medical Power Adapter, Right AngleVisby Medical, Inc.OUY2023-04-19
15420045514966APTIMAHologic, Inc.QEP2022-07-28
15420045514973APTIMAHologic, Inc.QEP2022-07-28
15420045514980APTIMAHologic, Inc.QEP2022-07-28
15420045514980APTIMAHologic, Inc.OUY2022-07-28
15420045514997APTIMAHologic, Inc.OUY2022-07-28
15420045514997APTIMAHologic, Inc.QEP2022-07-28
15420045515000APTIMAHologic, Inc.OUY2022-07-28
15420045515000APTIMAHologic, Inc.QEP2022-07-28
00382904439040BD CTGCTV2 for BD MAX™ SystemBECTON, DICKINSON AND COMPANYOUY2022-07-14
00382904439897BD COR™ MXBECTON, DICKINSON AND COMPANYOUY2022-06-16
00382904439897BD COR™ MXBECTON, DICKINSON AND COMPANYQEP2022-06-16
00382904439798BD CTGCTV2BECTON, DICKINSON AND COMPANYOUY2022-06-08
00382904439798BD CTGCTV2BECTON, DICKINSON AND COMPANYQEP2022-06-08
00884999048591Alinity mABBOTT MOLECULAR INC.QEP2022-05-19