Wondfo Saliva Alcohol Test W53-S

GUDID 10816862020387

1-Strip; Alcohol Saliva Test

WONDFO USA CO., LTD.

Ethanol (ETOH) IVD, kit, colorimetric, rapid

• Primary Device ID: 10816862020387
• NIH Device Record Key: 2f829f7f-0b22-4e12-84c8-be96dfa82e16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wondfo Saliva Alcohol Test
• Version Model Number: W53-S
• Catalog Number: W53-S
• Company DUNS: 849098897
• Company Name: WONDFO USA CO., LTD.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com
• Phone: 630-468-2199
• Email: wondfo@wondfousa.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816862020380 [Primary]
GS1	00816862029383 [Unit of Use]
GS1	10816862020387 [Package]; Contains: 00816862020380; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111206

FDA Product Code

• DIC: Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

On-Brand Devices [Wondfo Saliva Alcohol Test]

• 00816862025385: 1-Strip; Alcohol Saliva Test
• 10816862020387: 1-Strip; Alcohol Saliva Test