Catalog Number

-

Brand Name

ABX PENTRA UREA CP

Version/Model Number

1220001641

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

K070146

Product Code

CDQ

Product Code Name

Urease And Glutamic Dehydrogenase, Urea Nitrogen

Public Device Record Key

7bdc6f2e-285b-46a5-b900-8d9b64dca53e

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

August 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-