Catalog Number

-

Brand Name

ABX PENTRA BILIRUBIN, DIRECT CP

Version/Model Number

1220001635

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

K060325

Product Code

CIG

Product Code Name

Diazo Colorimetry, Bilirubin

Public Device Record Key

f658397a-f578-4791-a585-485146025e78

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-