Catalog Number

02J27-025

Brand Name

UroVysion

Version/Model Number

02J27-025

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052,P030052

Product Code

NSD

Product Code Name

Test, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence

Public Device Record Key

2996fac6-e60a-4699-bdd2-5904aa7c6191

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

November 20, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-