Alere iCup DX Pro I-DXP-187-02

GUDID 00817405020294

Alere iCup DX Pro Integrated CLIA Waived Urine Drug Screening Device THC50, COC300, OPI300, AMP1000, MET1000, BZO300, MTD300, OXY100 with (Cr,S.G.,pH)

Instant Technologies, Inc.

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

• Primary Device ID: 00817405020294
• NIH Device Record Key: 928b6821-0b08-49dd-a1a1-f0a2734975e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere iCup DX Pro
• Version Model Number: I-DXP-187-02
• Catalog Number: I-DXP-187-02
• 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: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4029
• Email: lisa.bates@alere.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817405020294 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082898

FDA Product Code

• DJR: Enzyme Immunoassay, Methadone

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: 2019-01-07
• Device Publish Date: 2018-12-06

On-Brand Devices [Alere iCup DX Pro]

• 00817405020317: Urine Drug Screening Device for detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine,
• 00817405020300: Urine Drug Screening Device for detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine,
• 00817405020294: Alere iCup DX Pro Integrated CLIA Waived Urine Drug Screening Device THC50, COC300, OPI300, AMP1