Catalog Number

GEN-DBILI R2

Brand Name

GENCHEM™ Direct Bilirubin Reagent

Version/Model Number

GEN-DBILI R2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 19, 2020

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

CIG

Product Code Name

DIAZO COLORIMETRY, BILIRUBIN

Public Device Record Key

c9178956-abe3-43ee-a28a-bad9e2c55b1b

Public Version Date

October 21, 2022

Public Version Number

4

DI Record Publish Date

September 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-