Single Drug Urine Test Panel AWDMD-114

GUDID 00817405021123

MDMA Single Drug Urine Test Panel

Instant Technologies, Inc.

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

• Primary Device ID: 00817405021123
• NIH Device Record Key: 0859dc42-91df-4d6f-9e07-01b2c6d81e43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Drug Urine Test Panel
• Version Model Number: AWDMD-114
• Catalog Number: AWDMD-114
• 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: true
• OTC Over-The-Counter: true

Customer Support Contacts

• 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
• 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
• 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	00817405021123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

FDA Product Code

• LAF: Gas Chromatography, Methamphetamine

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: 2020-03-18
• Device Publish Date: 2020-03-10

On-Brand Devices [Single Drug Urine Test Panel]

• 00817405021123: MDMA Single Drug Urine Test Panel
• 00817405021093: Morphine (MOP) Single Drug Urine Test Panel