Catalog Number

6844296

Brand Name

VITROS

Version/Model Number

6844296

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K190807

Product Code

CIG

Product Code Name

DIAZO COLORIMETRY, BILIRUBIN

Public Device Record Key

b4878c8b-4c55-4dd1-8591-903fa386a99a

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

November 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-