FDA.reportPublic FDA data

Aptima

Primary DI
15420045511835
Brand
Aptima
Company
Hologic, Inc.
Model
AC2, 250T, RMR, (RT)
Catalog number
PRD-04843
Published
2019-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LSLDNA-REAGENTS, NEISSERIA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSLDna-Reagents, NeisseriaMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132251000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132251000APTIMA COMBO 2 ASSAY (PANTHER SYSTEM)Hologic / Gen-Probe Incorporated2013-10-17LSL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045511835PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551183515420045511835

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

Regulatory Flags#

DUNS number
050579217
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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 COMPANYLSL2024-05-16
30382904402960BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYLSL2024-02-26
30382904439232BD Molecular LBC Sample Buffer TubesBECTON, DICKINSON AND COMPANYLSL2024-02-23
15420045511880Aptima®Hologic, Inc.LSL2023-10-26
00884999051096Alinity mABBOTT MOLECULAR INC.LSL2023-09-14
00810031720064Visby Medical Sexual Health TestVisby Medical, Inc.LSL2023-04-19
10810031720061Visby Medical Sexual Health TestVisby Medical, Inc.LSL2023-04-19
00810031720071Visby Medical Power Adapter, Right AngleVisby Medical, Inc.LSL2023-04-19
15420045514966APTIMAHologic, Inc.LSL2022-07-28
15420045514973APTIMAHologic, Inc.LSL2022-07-28
00382904439040BD CTGCTV2 for BD MAX™ SystemBECTON, DICKINSON AND COMPANYLSL2022-07-14
00382904439897BD COR™ MXBECTON, DICKINSON AND COMPANYLSL2022-06-16
00382904439798BD CTGCTV2BECTON, DICKINSON AND COMPANYLSL2022-06-08
00884999048898Alinity mABBOTT MOLECULAR INC.LSL2022-05-18
00884999047686Alinity mABBOTT MOLECULAR INC.LSL2022-05-18
00884999047693Alinity mABBOTT MOLECULAR INC.LSL2022-05-18
00884999049314Alinity mABBOTT MOLECULAR INC.LSL2022-05-18
00810031720002Visby Medical Sexual Health Click TestVisby Medical, Inc.LSL2021-09-15
00810031720033Visby Medical Power AdapterVisby Medical, Inc.LSL2021-09-15
00810031720057Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 PackVisby Medical, Inc.LSL2021-09-15
15420045512832Aptima Combo 2®Hologic, Inc.LSL2020-06-16
15420045512849Aptima Combo 2®Hologic, Inc.LSL2020-06-16
15420045512894Aptima Combo 2®Hologic, Inc.LSL2020-06-16
15420045512900Aptima Combo 2®Hologic, Inc.LSL2020-06-16
15420045511842AptimaHologic, Inc.LSL2019-09-26
00382904411268BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA AssayBECTON, DICKINSON AND COMPANYLSL2018-05-25
00382904429706BD MAX™ CT/GC/TVBECTON, DICKINSON AND COMPANYLSL2018-05-25