Mission Saliva Test Strips

GUDID 20682607200058

Mission Saliva Alcohol Test Strips

ACON LABORATORIES, INC.

Ethanol (ETOH) IVD, kit, colorimetric, rapid

• Primary Device ID: 20682607200058
• NIH Device Record Key: 96e37f4c-a20f-4aa8-8822-24304df923e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mission Saliva Test Strips
• Version Model Number: C031-021
• Company DUNS: 781100966
• Company Name: ACON LABORATORIES, INC.
• Device Count: 25
• 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: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 81 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00682607000272 [Unit of Use]
GS1	00682607200054 [Primary]
GS1	20682607200058 [Package]; Contains: 00682607200054; Package: Carton [80 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093879

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: 2016-09-26

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