FDA.reportPublic FDA data

Aptima®

Primary DI
15420045506435
Brand
Aptima®
Company
Hologic, Inc.
Model
APTIMA GPRS, 250 TESTS (RT)
Catalog number
302070
Device description
Aptima® General Purpose Reagents, 250 test, box 1 of 2 (15°C to 30°C box). The Aptima® General Purpose Reagents (GPRs) feature Transcription-Mediated Amplification (TMA®) and Hybridization Protection Assay (HPA) technologies. Aptima® GPRs may be used to facilitate the development of tests by CLIA-certified high complexity laboratories or research laboratories for the qualitative detection of nucleic acid-based analytes.
Published
2016-05-02
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
LSLDNA-REAGENTS, NEISSERIA
PPMGeneral purpose reagent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSLDna-Reagents, NeisseriaMicrobiology2
PPMGeneral Purpose ReagentPathology1

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
15420045506435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550643515420045506435

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
Premarket 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
00846405020331Diagnostic BioSystemsDiagnostic Biosystems, Inc.PPM2026-04-30
10845357044409Helix Elite™ Molecular Standards: Inactivated StandardMICROBIOLOGICS INC.PPM2026-04-15
08435804523417Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07
08435804524551Master Polymer Plus Detection System (Phosphatase)VITRO SAPPM2026-04-07
05407010128222Bulk Packaged ster. filtered WFI - 500mlLonza VerviersPPM2026-03-30
054070101286350.1 M NaCl Module L : 1L Bag SAMPLELonza VerviersPPM2026-03-30
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
00630414289984Atellica HEMA CleanerSiemens Healthcare Diagnostics Inc.PPM2026-02-06
00630414290034Atellica HEMA DeconSiemens Healthcare Diagnostics Inc.PPM2026-02-06
04049016152019EUROSORB (IFA)EUROIMMUN Medizinische Labordiagnostika AGPPM2025-11-21
04015630972531ultraView Silver Wash IIVentana Medical Systems, Inc.PPM2025-10-25
05407010129038Buffer FCM-G1 - 1000L bagLonza VerviersPPM2025-10-03
05407010129045Buffer FCM-G1 - 1L Bag SAMPLELonza VerviersPPM2025-10-03
054070101274300.4 M NaCl Module L : 500L BagLonza VerviersPPM2025-05-27
05407010127447Bulk Packaged ster filtered WFI-50LSSBLonza VerviersPPM2025-05-27
20812747018590Antiplatelet ReagentHAEMONETICS CORPORATIONPPM2025-05-20
00613647028308FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.PPM2025-04-30
00613647028414FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.PPM2025-04-30
00613647028421FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.PPM2025-04-30
00613647028445FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.PPM2025-04-30
00613647028452FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.PPM2025-04-30
00613647028469FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.PPM2025-04-30
00613647028476FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.PPM2025-04-30
00613647028483FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.PPM2025-04-30
00613647028490FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.PPM2025-04-30
00613647028520FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.PPM2025-04-30
00613647028537FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.PPM2025-04-30
B645T0453EDGE BIOLOGICALS INCEDGE BIOLOGICALS, INC.PPM2025-04-21