iCup™ DUE-167-342
iCup DUE-167-342 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 00817405022991), 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 | Number00817405022991 | Date6 Feb 2023 | StatusListed |
Official records
- AccessGUDID record 00817405022991
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- Withdrawn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
- DUE-167-342
- Primary DI / UDI-DI
- 00817405022991
- FDA product code
- DIO, DJG, DJR, LDJ, LAF
- GMDN term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.3250, 862.3650, 862.3620, 862.3870, 862.3610
- GUDID distribution status
- In Commercial Distribution
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