FDA.reportPublic FDA data

Progensa

Primary DI
15420045500792
Brand
Progensa
Company
Hologic, Inc.
Model
PCA3 CALIBRATORS AND CONTROLS
Catalog number
302353
Published
2014-09-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OYMProstrate cancer genes nucleic acid amplification test system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OYMProstrate Cancer Genes Nucleic Acid Amplification Test SystemUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100033001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100033001PROGENSA PCA3 ASSAYGen-Probe Incorporated2012-02-13OYM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045500792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004550079215420045500792

GMDN Terms#

Term, Definition table
TermDefinition
Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of mRNA expression of the prostate cancer gene 3 (PCA3) and the gene coding for the prostate specific antigen associated with prostate cancer, in a clinical specimen.

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
Kit
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
15420045500730ProgensaHologic, Inc.OYM2014-09-18
15420045500747ProgensaHologic, Inc.OYM2014-09-17
15420045500754ProgensaHologic, Inc.OYM2014-09-17
15420045500761ProgensaHologic, Inc.OYM2014-09-17
15420045500808ProgensaHologic, Inc.OYM2014-09-17
15420045500815ProgensaHologic, Inc.OYM2014-09-17
15420045500822ProgensaHologic, Inc.OYM2014-09-17