Catalog Number

-

Brand Name

Detector UA 2GP

Version/Model Number

IDU-2GP

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

-

Product Code

CDM

Product Code Name

DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)

Public Device Record Key

cf1829dc-ca1e-4e30-8919-f13f39ffa8ae

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

November 20, 2018

Package DI Number

20722355002914

Quantity per Package

12

Contains DI Package

10722355002917

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-