iCassette™ DAM-102
iCassette DAM-102 is a multiple drugs of abuse IVD (FDA Class II; FDA product code DKZ, Enzyme Immunoassay, Amphetamine) made by Instant Technologies, Inc., listed in FDA GUDID since 7 Feb 2023 (UDI-DI 00817405022533), 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 | Number00817405022533 | Date7 Feb 2023 | StatusListed |
Official records
- AccessGUDID record 00817405022533
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- iCassette™
- Generic name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Model / Ref / Catalog
- DAM-102
- Primary DI / UDI-DI
- 00817405022533
- FDA product code
- DKZ
- GMDN term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.3100
- GUDID distribution status
- In Commercial Distribution
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- Atellica CH Amp 11097506 by Siemens Healthcare Diagnostics Inc.
- WONDFO AMPHETAMINE URINE TEST, WONDFO BARBITURATES URINE TEST, WONDFO BENZODIAZEPINES URINE TEST by Guangzhou Wondfo Biotech Co., Ltd.
- Target Amphetamine/Methamphetamine-r (Reader Meth) by V-Tech, Inc.
- Ontrak Testcup 502, Model 3016641 by Roche Diagnostics Corp.