T-Cube® Tcube-10MO

GUDID 00858945006874

T-Cube ® One Step Multi-Drug Oral Fluid Test Cube offers qualitative detection of the following drugs of abuse and their principal metabolites in human oral fluid at specified cut-off levels for use in employment and insurance testing: AMP, MET, BAR, BZO, COC, OPI, OXY, THC, MDMA, MTD.

Instant Technologies, Inc.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00858945006874
• NIH Device Record Key: e77618e4-a045-4c27-827e-658c2c7f6043
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-Cube®
• Version Model Number: Tcube-10MO
• Catalog Number: Tcube-10MO
• Company DUNS: 019410187
• Company Name: Instant Technologies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858945006874 [Primary]

FDA Product Code

• PVJ: Test, Cannabinoid, Employment And Insurance Testing, Exempt

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2018-02-09

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