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
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 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