FDA.reportPublic FDA data

Aptima®

Primary DI
15420045500082
Brand
Aptima®
Company
Hologic, Inc.
Model
KIT,HPV,APTIMA, CONTROLS, IVD
Catalog number
303011
Device description
Aptima® HPV Assay Controls Kit.
Published
2014-07-30
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
OYBKit, rna detection, human papillomavirus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OYBKit, Rna Detection, Human PapillomavirusUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100042001
P100042002
P100042004
P100042012
P100042013
P100042020
P100042022
P100042024
P100042027
P100042028
P100042032
P100042034

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100042001APTIMA HPV ASSAYGen-Probe Incorporated2011-10-28OYB
P100042002APTIMA HPV ASSAYGen-Probe Incorporated2011-10-28OYB
P100042004APTIMA HPV ASSAYGen-Probe Incorporated2011-10-28OYB
P100042012APTIMA HPV ASSAYGen-Probe Incorporated2011-10-28OYB
P100042013APTIMA HPV ASSAYGen-Probe Incorporated2011-10-28OYB
P100042020APTIMA HPV ASSAYGen-Probe Incorporated2011-10-28OYB
P100042022APTIMA HPV ASSAYGen-Probe Incorporated2011-10-28OYB
P100042024APTIMA HPV ASSAYGen-Probe Incorporated2011-10-28OYB
P100042027APTIMA HPV ASSAYGen-Probe Incorporated2011-10-28OYB
P100042028APTIMA HPV ASSAYGen-Probe Incorporated2011-10-28OYB
P100042032APTIMA HPV ASSAYGen-Probe Incorporated2011-10-28OYB
P100042034APTIMA HPV ASSAYGen-Probe Incorporated2011-10-28OYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045500082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550008215420045500082

GMDN Terms#

Term, Definition table
TermDefinition
Human papillomavirus (HPV) high-risk strain nucleic acid IVD, controlA material that is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple high-risk strains of human papillomavirus (HPV) associated with cervical cancer, which may include types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and/or 68 in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 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
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
15420045500051Aptima®Hologic, Inc.OYB2014-07-30
15420045500068Aptima®Hologic, Inc.OYB2014-07-30
15420045500075Aptima®Hologic, Inc.OYB2014-07-30
15420045500099Aptima®Hologic, Inc.OYB2014-07-30
15420045500105Aptima®Hologic, Inc.OYB2014-07-30
15420045500112Aptima®Hologic, Inc.OYB2014-07-30
15420045500129Aptima®Hologic, Inc.OYB2014-07-30
15420045500136Aptima®Hologic, Inc.OYB2014-07-30