Wondfo - 100-Strips; Alcohol Saliva Test Box 100 Pcs - WONDFO USA CO., LTD.

Duns Number:849098897

Device Description: 100-Strips; Alcohol Saliva Test Box 100 Pcs

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More Product Details

Catalog Number

W53-S-100BX

Brand Name

Wondfo

Version/Model Number

W53-S-100BX

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K133968,K133968,K133968

Product Code Details

Product Code

DIC

Product Code Name

Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Device Record Status

Public Device Record Key

c5aa2e4d-aa0d-4dfb-80d6-1867b724096b

Public Version Date

October 31, 2022

Public Version Number

3

DI Record Publish Date

August 20, 2021

Additional Identifiers

Package DI Number

10816862023012

Quantity per Package

25

Contains DI Package

00816862023015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"WONDFO USA CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 87
U Unclassified 1