Alere iCup Dx Pro 2

GUDID 00817405021062

iCup Dx Pro 2 Integrated CLIA Waived Cup with Adulterants (CR, NI, OX, pH, SG) 10 Panel Drug Screen for AMP1000, BAR300, BZO300, COC300, MDMA500, MET1000, MTD300, OPI2000, OXY100, THC50

Instant Technologies, Inc.

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

• Primary Device ID: 00817405021062
• NIH Device Record Key: 86fd3fcb-3942-462d-9ba2-e3c8b08463f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere iCup Dx Pro 2
• Version Model Number: I-DXP-10
• 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
• 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
• 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	00817405021062 [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: 2019-10-16
• 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