AlcoCheck 40900

GUDID B298409000

Saliva Alcohol Test

EXPRESS DIAGNOSTICS INT'L, INC.

Ethanol (ETOH) IVD, kit, colorimetric, rapid

• Primary Device ID: B298409000
• NIH Device Record Key: bfe6cf2f-77c8-4548-add6-9adb5221635d
• Commercial Distribution Discontinuation: 2019-05-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AlcoCheck
• Version Model Number: 40900
• Catalog Number: 40900
• Company DUNS: 168560402
• Company Name: EXPRESS DIAGNOSTICS INT'L, INC.
• Device Count: 1
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com
• Phone: 507-526-3951
• Email: quality@drugcheck.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B298409000 [Primary]

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: 4
• Public Version Date: 2019-05-03
• Device Publish Date: 2017-02-20