Alere iCUP DX I-DXA-13B

GUDID 00817405020379

Alere iCUP DX (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+(BAR300/MTD300)+(MDMA500/OXY100) +(BUPG10/TCA1000)+PCP25 With Cr, Ni, pH, Bl, S.G.

Instant Technologies, Inc.

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

• Primary Device ID: 00817405020379
• NIH Device Record Key: 9dad3610-f876-43ee-8300-a278c5129372
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere iCUP DX
• Version Model Number: I-DXA-13B
• Catalog Number: I-DXA-13B
• 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: 1-800-340-4028
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4028
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4028
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4028
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4028
• Email: lisa.bates@alere.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4028
• Email: Qa.Portsmouth@abbott.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817405020379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122633

FDA Product Code

• DIS: Enzyme Immunoassay, Barbiturate

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-15
• Device Publish Date: 2018-03-23

On-Brand Devices [Alere iCUP DX]

• 00817405020386: Alere iCUP DX (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+(BAR300/MTD300)+(MDMA500/OXY100) Wi
• 00817405020379: Alere iCUP DX (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+(BAR300/MTD300)+(MDMA500/OXY100) +(
• 00817405020348: Drugs of Abuse Test Cup for detection of BZO+BAR+(MET/OPI)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+COC wi
• 00817405020331: Drugs of Abuse Test Cup for detection of BZO+BAR+(MET1000/OPI2000)+(OXY/MDMA)+AMP+COC+MTD+THC wi
• 00817405020324: Drugs of Abuse Test Cup for detection of BZO+BAR+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MDMA
• 00817405020263: Drugs of Abuse Test Cup for detection of (BZO/BAR)+(MET/OPI)+(MTD/TCA)+(OXY/MDMA)+(PCP/AMP)+COC
• 00817405020256: Drugs of Abuse Test Cup for detection of (MET1000/OPI2000)+AMP+BZO+COC+MTD+OXY+THC with adultera
• 00817405020249: Drugs of Abuse Test Cup for detection of (BZO/BAR)+(MET1000/OPI2000)+(OXY/MDMA)+AMP+COC+MTD+THC
• 00817405020232: Drugs of Abuse Test Cup for detection of (BZO/BAR)+(COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+(OXY/MD
• 00817405020225: Drugs of Abuse Test Cup for detection of COC/THC/OPI/MET/BZO/OXY with adulteration tests Cr, Ni,