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.

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• 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