Catalog Number

AU-421

Brand Name

CAROLINA LIQUID CHEMISTRIES CORP.® ETHA RGT. KIT AU-421

Version/Model Number

AU-421

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

Yes

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

-

FDA Premarket Submission

-

Product Code

DIC

Product Code Name

ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD

Public Device Record Key

5691be36-17a1-4d32-91a3-2ce27260a043

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-