FDA.reportPublic FDA data

Aptima®

Primary DI
15420045500112
Brand
Aptima®
Company
Hologic, Inc.
Model
KIT, APTIMA HPV 16 18/45, 100 REF IVD
Catalog number
303230
Device description
Aptima® HPV 16 18/45 Genotype Assay, 100 test, box 1 of 2 (2°C to 8°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
15420045500112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550011215420045500112

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 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
05420045503888SecurMarkSMARK-U-SS1SMARK-U-SS12015-09-04
05420045503895SecurMarkSMARK-U-SS2SMARK-U-SS22015-09-04
05420045503901SecurMarkSMARK-U-SS3SMARK-U-SS32015-09-04
15420045511859Unifi WorkspaceUnifi Workspace V1.02019-08-09
15420045515307Acessa ProVu System710071002023-05-16
15420045515314Acessa ProVu SystemMS-06-0171MS-06-01712023-05-16
15420045515284Acessa ProVu System520052002022-11-08
15420045513983BioZorbF0202F02022021-04-21
15420045513990BioZorbF0203F02032021-04-21
15420045514003BioZorbF0303F03032021-04-21
15420045514010BioZorbF0304F03042021-04-21
15420045514027BioZorbF0221F02212021-04-21
15420045514034BioZorbF0231F02312021-04-21
15420045514041BioZorbF0331F03312021-04-21
15420045514058BioZorbF0404F04042021-04-21
15420045514065BioZorbF0405F04052021-04-21
15420045512634Unifi WorkspaceUnifi Workspace V1.02020-09-21
15420045500020Selenia Dimensions C-View SoftwareC-ViewSW-030522014-09-05
15420045504561ATEC IntroducerAI090920AI0909202016-08-11
15420045504578ATEC IntroducerAI091220AI0912202016-08-11

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
15420045500129Aptima®Hologic, Inc.OYB2014-07-30
15420045500136Aptima®Hologic, Inc.OYB2014-07-30