Catalog Number

-

Brand Name

Bun Rate Reagent

Version/Model Number

R82043

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K012649

Product Code

CDQ

Product Code Name

Urease And Glutamic Dehydrogenase, Urea Nitrogen

Public Device Record Key

b4fe56b6-f542-46ad-bd6c-300ced8f5a0b

Public Version Date

February 04, 2019

Public Version Number

5

DI Record Publish Date

August 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-