Catalog Number

W53-S-25BX

Brand Name

Wondfo

Version/Model Number

W53-S-25BX

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K111206,K111206,K111206

Product Code

DIC

Product Code Name

Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Public Device Record Key

ad1c46ad-4643-4d05-8736-9caf1ed6832b

Public Version Date

August 30, 2021

Public Version Number

1

DI Record Publish Date

August 20, 2021

Package DI Number

10816862022992

Quantity per Package

168

Contains DI Package

00816862022995

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-