FDA.reportPublic FDA data

Aptima®

Primary DI
15420045500075
Brand
Aptima®
Company
Hologic, Inc.
Model
KIT,HPV,APTIMA, CALIBRATORS, IVD
Catalog number
303010
Device description
Aptima® HPV 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
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
15420045500075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550007515420045500075

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