Alere iCup Dx Pro 2

GUDID 00817405021055

iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR, NI, OX, pH, SG) 5 Panel Drug Screen for AMP1000, COC300, OPI2000, PCP25, THC50

Instant Technologies, Inc.

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• Primary Device ID: 00817405021055
• NIH Device Record Key: e63e7c7c-82b9-4663-99dd-2d83755999d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere iCup Dx Pro 2
• Version Model Number: I-DXP-5A
• 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	00817405021055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

FDA Product Code

• LCM: Enzyme Immunoassay, Phencyclidine

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: 2019-10-16
• Device Publish Date: 2019-10-08

On-Brand Devices [Alere iCup Dx Pro 2]

• 00817405020362: iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (CO
• 00817405020355: iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (A
• 00817405020287: iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for(AMP
• 00858945006836: iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 7 Panel Drug Screen for(AMP
• 00858945006829: iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (A
• 00858945006812: iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 6 Panel Drug Screen for (CO
• 00817405021079: iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR, NI, OX, pH, SG) 5 Panel Drug Scre
• 00817405021062: iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR, NI, OX, pH, SG) 10 Panel Drug Scr
• 00817405021055: iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR, NI, OX, pH, SG) 5 Panel Drug Scre