Catalog Number

W53-S

Brand Name

Wondfo Saliva Alcohol Test

Version/Model Number

W53-S

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)

Yes

Over the Counter (OTC)

Yes

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

2f829f7f-0b22-4e12-84c8-be96dfa82e16

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10816862020387

Quantity per Package

25

Contains DI Package

00816862020380

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-