FDA.reportPublic FDA data

Aptima®

Primary DI
15420045500242
Brand
Aptima®
Company
Hologic, Inc.
Model
KIT, AC2 ASSAY FL, TIG, IVD-CE (302382)
Catalog number
302382
Device description
The Aptima® Assay Fluids Kit is used with the Aptima® Assays on the Tigris® DTS® System. Use the Assay Fluids Kit according to the instructions outlined in the appropriate assay package insert and the Tigris® DTS® System Operator’s Manual.
Published
2014-09-17
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
MKZDNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LSLDna-Reagents, NeisseriaMicrobiology2
MKZDna Probe, Nucleic Acid Amplification, ChlamydiaMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003395000
K060652000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003395000GEN-PROBE APTIMA COMBO 2 ASSAYGen-Probe, Inc.2001-05-21LSL
K060652000TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAYGen-Probe, Inc.2006-08-17LSL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045500242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550024215420045500242

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid technique (NAT) kit IVDA collection of reagents and other associated materials intended to be used to optimise an assay performed using a nucleic acid technique (NAT) on a clinical specimen. The kit typically consists of a silicone oil to minimize evaporation, buffered solutions for washing steps and reaction stop reagents.

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
Lot or batch
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

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Primary DI, Brand, Company table
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00875197007275cobas® liat CT/NGRoche Molecular Systems, Inc.LSL2026-02-24
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00382904402969BD Molecular Swab Sample Buffer TubesBECTON, DICKINSON AND COMPANYMKZ2024-02-26
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