iCup® I-DOA-167-1111

GUDID 10858945006840

A rapid, one step screening test for the simultaneous, qualitative detection of multiple drugs and drug metabolites in human urine.

Instant Technologies, Inc.

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

• Primary Device ID: 10858945006840
• NIH Device Record Key: cffc5a71-443b-4190-bf26-143d1dc0d6dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iCup®
• Version Model Number: I-DOA-167-1111
• Catalog Number: I-DOA-167-1111
• 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
• 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	00858945006843 [Unit of Use]
GS1	10858945006840 [Primary]

FDA Product Code

• DIO: Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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: 2021-01-12
• Device Publish Date: 2017-05-08

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