Catalog Number

302352

Brand Name

Progensa

Version/Model Number

PCA3 URINE TRANSPORT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P100033,P100033

Product Code

OIE

Product Code Name

Urine collection kit (excludes hiv testing)

Public Device Record Key

7c3d4215-5f23-4011-9f4c-66a58cb70f7a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 17, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-