Catalog Number

DF75A

Brand Name

Dimension® Flex® reagent cartridge TU

Version/Model Number

10444912

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

K862359,K862359

Product Code

CIG

Product Code Name

DIAZO COLORIMETRY, BILIRUBIN

Public Device Record Key

2de2f4f7-17e0-4d3c-b7c0-17181efd4a89

Public Version Date

December 10, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-