Progensa 302353

GUDID 15420045500792

Hologic, Inc.

Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, control Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, control
Primary Device ID15420045500792
NIH Device Record Keye1d245a0-4c0b-41c8-972a-bb425abe1056
Commercial Distribution StatusIn Commercial Distribution
Brand NameProgensa
Version Model NumberPCA3 CALIBRATORS AND CONTROLS
Catalog Number302353
Company DUNS050579217
Company NameHologic, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045500792 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OYMProstrate cancer genes nucleic acid amplification test system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-17

On-Brand Devices [Progensa]

25420045500775PCA3 URINE TRANSPORT
15420045500822URINE SPECIMENT TRANSPORT TUBES
15420045500815PCA3 SPECIMEN DILUENT KIT
15420045500808PSA CALIBRATORS AND CONTROLS
15420045500792PCA3 CALIBRATORS AND CONTROLS
15420045500785ASSAY FLUIDS KIT
15420045500761PSA
15420045500754PSA
15420045500747PCA3
15420045500730PCA3

Trademark Results [Progensa]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROGENSA
PROGENSA
78939219 3490604 Live/Registered
GEN-PROBE INCORPORATED
2006-07-27
PROGENSA
PROGENSA
78076672 not registered Dead/Abandoned
Rose, John, R.
2001-07-31

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