T-Cup® Compact ACDOA-6125

GUDID 00817504020560

T-Cup® Compact Multi-Drug Urine Test Cup

Instant Technologies, Inc.

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

• Primary Device ID: 00817504020560
• NIH Device Record Key: aa292052-cf0c-43d6-bb88-a8bf5ae462a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-Cup® Compact
• Version Model Number: ACDOA-6125
• Catalog Number: ACDOA-6125
• Company DUNS: 019410187
• Company Name: Instant Technologies, 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: 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: qa.portsmouth@alere.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817504020560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-01
• Device Publish Date: 2019-04-23

On-Brand Devices [T-Cup® Compact ]

• 00817504020560: T-Cup® Compact Multi-Drug Urine Test Cup
• 00817405021048: T-Cup® Compact Multi-Drug Urine Test Cup
• 00817405021031: T-Cup® Compact Multi-Drug Urine Test Cup
• 00817405021024: T-Cup® Compact Multi-Drug Urine Test Cup
• 00817405021017: T-Cup® Compact Multi-Drug Urine Test Cup
• 00817405021000: T-Cup® Compact Multi-Drug Urine Test Cup
• 00817405020560: T-Cup® Compact Multi-Drug Urine Test Cup
• 10817405021298: UScreen Squared Integrated CLIA Waived Cup with Adulterants (CR/NI/pH/OX/SG) 14 Panel Drug Scree