Urine Dip Card ATS-TRAM

GUDID 00858945006935

Single Drug Urine Test Panel, Opiates, Employment and Insurance Testing, Exempt: TRA.

Instant Technologies, Inc.

Opiate/opiate metabolite IVD, kit, immunochromatographic test (ICT)

• Primary Device ID: 00858945006935
• NIH Device Record Key: 3492712c-8832-44c8-b5b5-816ae067d980
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Urine Dip Card
• Version Model Number: ATS-TRAM
• Catalog Number: ATS-TRAM
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858945006935 [Primary]

FDA Product Code

• PVH: Test, Opiates, 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

On-Brand Devices [Urine Dip Card]

• 00858945006959: Single Drug Urine Test Panel, Fentanly, Employment And Insurance Testing, Exempt: FTY.
• 00858945006942: Single Drug Urine Test Panel, Synthetic Cannabinoids, Employment And Insurance Testing, Exempt:
• 00858945006935: Single Drug Urine Test Panel, Opiates, Employment and Insurance Testing, Exempt: TRA.