iCup®

GUDID 10858945006284

Instant Technologies, Inc.

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

• Primary Device ID: 10858945006284
• NIH Device Record Key: e3eb1e92-5a84-4165-82bd-a8f4823de22f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iCup®
• Version Model Number: I-DUE-1107-141
• Company DUNS: 019410187
• Company Name: Instant Technologies, Inc.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858945006287 [Unit of Use]
GS1	10858945006284 [Primary]

FDA Product Code

• LFG: Radioimmunoassay, Tricyclic Antidepressant Drugs

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: 2020-12-11
• Device Publish Date: 2016-09-27

On-Brand Devices [iCup®]

• 10858945006338: I-DUE-197-221
• 10833143000050: One Step Multi-Drug Screen Test Card with the Integrated iCup® (CR/OX/pH)+ +++
• 10858945006321: I-DUE-1107-291
• 10858945006314: I-DUE-167-012
• 10858945006307: I-DUE-167-342
• 10858945006291: I-DUD-187-013
• 10858945006284: I-DUE-1107-141
• 10858945006277: I-DUD-1107-012
• 10858945006260: I-DUD-197-014
• 10858945006253: I-DUA-147-012
• 10858945006222: i-DOA-197-041
• 10858945006215: I-DUA-197-013
• 10858945006192: I-DUA-157-115
• 10858945006185: I-DUA-157-034
• 10858945006178: I-DUE-187-071
• 10858945006154: I-DUE-1127-022
• 10858945006147: i-DUA-167-291
• 10858945006130: I-DUA-167-022
• 10858945006123: i-DOA-11107
• 10858945006116: I-DUE-1117-101
• 10858945006109: i-DOA-3137
• 10858945006093: I-DUA-157-023
• 10858945006086: I-DUA-167-012
• 10858945006079: I-DUA-157-013
• 10858945006048: I-DOA-1107-331
• 10858945006031: I-DOA-1107-113
• 10858945006024: I-DUE-187-241
• 10858945006017: i-DOA-1237
• 10858945006000: I-DOA-177-031
• 10833143000043: One Step Multi-Drug Screen Test Card with the Integrated iCup® (Oxidants/Specific Gravity/pH)+
• 10833143000036: One Step Multi-Drug Screen Test Card with the Integrated iCup® MTD>++(BZO/BAR)+(mAMP/OPI/P
• 10858945006840: A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs a
• 10858945006208: I-DUA-187-012
• 10858945006161: I-DUE-147-241
• 10858945006062: I-DOA-197-251
• 10858945006055: I-DOA-1117-111
• 10858945006826: I-DUD-177-461
• 10858945006819: I-DUE-197-261
• 10858945006246: I-DOA-1137-011
• 10858945006239: i-DOA-1107-051
• 00817405021345: iCup® E&I Urine Test 6 Panel Drug Screen Cup w/SVT (CR/pH/SG) (AMP1000/COC300/MET1000/OPI2000/O
• 00817405021338: iCup® E&I Urine Test 11 Panel Drug Screen Cup w/SVT (CR/pH/SG) (AMP1000/BAR300/BZO300/BUP10/COC