iCup™ DOA-177-031
iCup DOA-177-031 is a multiple drugs of abuse IVD (FDA Class II) made by Instant Technologies, Inc., listed in FDA GUDID since 6 Feb 2023 (UDI-DI 00817405022694), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817405022694 | Date6 Feb 2023 | StatusListed |
Official records
- AccessGUDID record 00817405022694
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- iCup™
- Generic name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- DOA-177-031
- Primary DI / UDI-DI
- 00817405022694
- FDA product code
- DJG, DKZ, DIO, LDJ, LCM, LAF
- GMDN term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.3650, 862.3100, 862.3250, 862.3870, 862.3610
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code DJG (Enzyme Immunoassay, Opiates).
- OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS by Lin-Zhi International, Inc.
- LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) by Hangzhou Laihe Biotech Co., Ltd.
- REVISED LABELING FOR MORPHINE TEST KIT by Roche Diagnostic Systems, Inc.
- ACCUSIGN DOA3, DOA, COC/THC/OPI2000 DOA3; BIOSIGN DOA3, COC/THC/OPI2000; STATUS DS COC/THC/OPI2000 by PRINCETON BIOMEDITECH CORP.
- Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive by Siemens Healthcare Diagnostics
- Dimension Vista Flex Reagent Cartridge OXY 11533384 K5098 by Siemens Healthcare Diagnostics Inc.
- MICROLINE SCREEN FOR OPIATES by Drug Screening Systems, Inc.
- EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229 by Syva Co., Dade Behring, Inc.
- Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls by Immunalysis Corporation
- VISUALINE II MORPHINE/OPIATES/HEROIN by Sun Biomedical Laboratories, Inc.