AccessGUDID - DEVICE: Progensa (15420045500815)

GUDID

Device Identifier (DI) Information

Brand Name: Progensa
Version or Model: PCA3 SPECIMEN DILUENT KIT
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 302351
Company Name: Hologic, Inc.

Primary DI Number: 15420045500815
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 050579217 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61188	Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OYM	Prostrate cancer genes nucleic acid amplification test system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: acc59657-befb-45eb-a578-aa952f9d7997
Public Version Date: June 28, 2024
Public Version Number: 4
DI Record Publish Date: September 17, 2014