Alco-Screen02

GUDID 00737051863109

ALCO-SCREEN02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative blood alcohol concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in-vitro diagnostic use. The assay is a disposable test for one-time use. 510K Cleared - CliaWaived

CHEMATICS, INC.

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• Primary Device ID: 00737051863109
• NIH Device Record Key: 67095d2e-7d6a-4865-bbfb-8ccc03dc8e8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alco-Screen02
• Version Model Number: 56001
• Company DUNS: 196929947
• Company Name: CHEMATICS, 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: false

Customer Support Contacts

• Phone: 1-800-348-5174
• Email: info@chematics.com
• Phone: 1-800-348-5174
• Email: info@chematics.com
• Phone: 1-800-348-5174
• Email: info@chematics.com
• Phone: 1-800-348-5174
• Email: info@chematics.com
• Phone: 1-800-348-5174
• Email: info@chematics.com
• Phone: 1-800-348-5174
• Email: info@chematics.com
• Phone: 1-800-348-5174
• Email: info@chematics.com
• Phone: 1-800-348-5174
• Email: info@chematics.com
• Phone: 1-800-348-5174
• Email: info@chematics.com
• Phone: 1-800-348-5174
• Email: info@chematics.com
• Phone: 1-800-348-5174
• Email: info@chematics.com
• Phone: 1-800-348-5174
• Email: info@chematics.com
• Phone: 1-800-348-5174
• Email: info@chematics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00737051863109 [Primary]
GS1	00737051863116 [Package]; Package: Box [24 Units]; In Commercial Distribution
GS1	00737051863123 [Package]; Contains: 00737051863116; Package: Case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121256

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: 2016-09-29

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• 00737051863109 - Alco-Screen02: 2018-07-06ALCO-SCREEN02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects relative blood alcohol concentrations (BAC) greater than or equal to 0.02%. Results are used for the diagnosis of alcohol intoxication. For in-vitro diagnostic use. The assay is a disposable test for one-time use. 510K Cleared - CliaWaived
• 00737051863109 - Alco-Screen02: 2018-07-06 ALCO-SCREEN02 is a qualitative screening test used to detect the presence of ethyl alcohol in human saliva. The test detects rel