FDA.reportPublic FDA data

Aptima®

Primary DI
15420045500129
Brand
Aptima®
Company
Hologic, Inc.
Model
KIT, APTIMA HPV 16 18/45, 100 RT IVD
Catalog number
303231
Device description
Aptima® HPV 16 18/45 Genotype Assay, 100 test, box 2 of 2 (15°C to 30°C box).
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
15420045500129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550012915420045500129

GMDN Terms#

Term, Definition table
TermDefinition
Human papillomavirus (HPV) high risk strain 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 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, using a nucleic acid technique (NAT).

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
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
15420045500136Aptima®Hologic, Inc.OYB2014-07-30