Wondfo Saliva Alcohol Test W53-S

GUDID 00816862025385

1-Strip; Alcohol Saliva Test

WONDFO USA CO., LTD.

Ethanol (ETOH) IVD, kit, colorimetric, rapid Ethanol (ETOH) IVD, kit, colorimetric, rapid Ethanol (ETOH) IVD, kit, colorimetric, rapid Ethanol (ETOH) IVD, kit, colorimetric, rapid Ethanol (ETOH) IVD, kit, colorimetric, rapid Ethanol (ETOH) IVD, kit, colorimetric, rapid Ethanol (ETOH) IVD, kit, colorimetric, rapid Ethanol (ETOH) IVD, kit, colorimetric, rapid Ethanol (ETOH) IVD, kit, colorimetric, rapid Ethanol (ETOH) IVD, kit, colorimetric, rapid Ethanol (ETOH) IVD, kit, colorimetric, rapid Ethanol (ETOH) IVD, kit, colorimetric, rapid Ethanol (ETOH) IVD, kit, colorimetric, rapid Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical Ethanol (ETOH) IVD, kit, rapid colorimetric, clinical
Primary Device ID00816862025385
NIH Device Record Key3d20035e-8461-4fc5-85c1-65f189d0e0e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameWondfo Saliva Alcohol Test
Version Model NumberW53-S
Catalog NumberW53-S
Company DUNS849098897
Company NameWONDFO USA CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com
Phone630-468-2199
Emailwondfo@wondfousa.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816862025385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

On-Brand Devices [Wondfo Saliva Alcohol Test]

008168620253851-Strip; Alcohol Saliva Test
108168620203871-Strip; Alcohol Saliva Test
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