iScreen™ DMA-U114
iScreen DMA-U114 is a multiple drugs of abuse IVD (FDA Class II; FDA product code LAF, Gas Chromatography, Methamphetamine) made by Instant Technologies, Inc., listed in FDA GUDID since 7 Feb 2023 (UDI-DI 00817405022083), 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 | Number00817405022083 | Date7 Feb 2023 | StatusListed |
Official records
- AccessGUDID record 00817405022083
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- iScreen™
- Generic name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- DMA-U114
- Primary DI / UDI-DI
- 00817405022083
- FDA product code
- LAF
- GMDN term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.3610
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Multiple drugs of abuse IVD, kit, rapid ICT, clinical.