FDA.reportPublic FDA data

Aptima®

Primary DI
15420045500105
Brand
Aptima®
Company
Hologic, Inc.
Model
KIT, BX 2 (RT) HPV,100-T,AS, US IVD
Catalog number
303572
Device description
Aptima® HPV 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
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
15420045500105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550010515420045500105

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
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
15420045500112Aptima®Hologic, Inc.OYB2014-07-30
15420045500129Aptima®Hologic, Inc.OYB2014-07-30
15420045500136Aptima®Hologic, Inc.OYB2014-07-30