Catalog Number

08445672190

Brand Name

Ethanol Gen.2

Version/Model Number

08445672190

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 03, 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

K951595

Product Code

DIC

Product Code Name

ALCOHOL DEHYDROGENASE, SPECIFIC REAGENT FOR ETHANOL ENZYME METHOD

Public Device Record Key

57aaa780-6be6-4675-86ea-6b2ab0362643

Public Version Date

November 27, 2020

Public Version Number

2

DI Record Publish Date

March 05, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-