DIW
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Hemagglutination Inhibition, Methadone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3620
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE (K950182) | E.I. Dupont DE Nemours & Co., Inc. | 1995-03-21 |
| ROCHE ABUSCREEN ONTRAK FOR METHADONE (K930845) | Roche Diagnostic Systems, Inc. | 1993-04-20 |
| HI-M-TEST FOR METHADONE TEST #2 (K801509) | Technam, Inc. | 1980-07-14 |
| KIT, METHADONE (TOXI-PAK IMMUNO HI) (K760075) | J.T. Baker Chemical Co. | 1976-07-20 |
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Every clearance here is in the API, with alerts when new ones post.