iCup™ DUA-197-013
iCup DUA-197-013 is a multiple drugs of abuse IVD (FDA Class II) made by Instant Technologies, Inc., listed in FDA GUDID since 7 Feb 2023 (UDI-DI 00817405022908), 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 | Number00817405022908 | Date7 Feb 2023 | StatusListed |
Official records
- AccessGUDID record 00817405022908
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- Withdrawn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
- DUA-197-013
- Primary DI / UDI-DI
- 00817405022908
- FDA product code
- LAF, DKZ, DIS, DIO, DJG, DJR, JXM, LDJ, LCM
- GMDN term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.3610, 862.3100, 862.3150, 862.3250, 862.3650, 862.3620, 862.3170, 862.3870
- GUDID distribution status
- In Commercial Distribution
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