Catalog Number

P080012

Brand Name

Pro Advantage

Version/Model Number

P080012

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

CDM

Product Code Name

Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)

Public Device Record Key

10463ff0-fc9e-4389-9696-4e5fe3e11987

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

February 13, 2017

Package DI Number

M220P0800125

Quantity per Package

24

Contains DI Package

M220P0800123

Package Discontinue Date

-

Package Status

-

Package Type

Case