FDA.reportPublic FDA data

Aptima®

Primary DI
15420045500136
Brand
Aptima®
Company
Hologic, Inc.
Model
KIT, APTIMA HPV 16 18/45, CALS IVD
Catalog number
303235
Device description
Aptima® GT HPV 16 18/45 Genotype Assay Calibrators 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
P120007001
P120007002
P120007003
P120007011
P120007018
P120007019
P120007022
P120007025
P120007026
P120007029
P120007030

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120007001APTIMA HPV 16 18/45 GENOTYPE ASSAYGen-Probe Incorporated2012-10-12OYB
P120007002APTIMA HPV 16 18/45 GENOTYPE ASSAYGen-Probe Incorporated2012-10-12OYB
P120007003APTIMA HPV 16 18/45 GENOTYPE ASSAYGen-Probe Incorporated2012-10-12OYB
P120007011APTIMA HPV 16 18/45 GENOTYPE ASSAYGen-Probe Incorporated2012-10-12OYB
P120007018APTIMA HPV 16 18/45 GENOTYPE ASSAYGen-Probe Incorporated2012-10-12OYB
P120007019APTIMA HPV 16 18/45 GENOTYPE ASSAYGen-Probe Incorporated2012-10-12OYB
P120007022APTIMA HPV 16 18/45 GENOTYPE ASSAYGen-Probe Incorporated2012-10-12OYB
P120007025APTIMA HPV 16 18/45 GENOTYPE ASSAYGen-Probe Incorporated2012-10-12OYB
P120007026APTIMA HPV 16 18/45 GENOTYPE ASSAYGen-Probe Incorporated2012-10-12OYB
P120007029APTIMA HPV 16 18/45 GENOTYPE ASSAYGen-Probe Incorporated2012-10-12OYB
P120007030APTIMA HPV 16 18/45 GENOTYPE ASSAYGen-Probe Incorporated2012-10-12OYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045500136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550013615420045500136

GMDN Terms#

Term, Definition table
TermDefinition
Human papillomavirus (HPV) high-risk strain nucleic acid IVD, calibratorA material that is used to establish known points of reference for 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
15420045500082Aptima®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