ProScreen PSD-5M
ProScreen PSD-5M, a multiple drugs of abuse IVD (FDA Class II) made by Instant Technologies, Inc., was listed in FDA GUDID on 14 Oct 2019 (UDI-DI 00817405020690); the registry lists it as not in commercial distribution (GUDID) 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 | Number00817405020690 | Date14 Oct 2019 | StatusListed |
Official records
- AccessGUDID record 00817405020690
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- ProScreen
- Generic name
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Model / reference
- PSD-5M
- Primary DI / UDI-DI
- 00817405020690
- FDA product code
- DKZ, DIO, DJC, DJG, LDJ
- GMDN term
- Multiple drugs of abuse IVD, kit, rapid ICT, clinical
- Device class
- Class II
- Regulation number
- 862.3100, 862.3250, 862.3610, 862.3650, 862.3870
- GUDID distribution status
- Not in Commercial Distribution
Similar devices
Other devices filed under FDA product code DKZ (Enzyme Immunoassay, Amphetamine).
- PSYCHEMEDICS MICROPLATE EIA FOR AMPHETAMINE by Psychemedics Corp.
- URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A by Dade Behring, Inc.
- QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9140-9147, 9061, 9066, 9071, 9076, 9081 AND 9131 by PHAMATECH INC.
- Syva® Emit® II Plus Amphetamines Assay 10445420 9C309UL by Siemens Healthcare Diagnostics Inc.
- Syva® RapidTest d.a.u.® AMP 10445350 6A059UL by Siemens Healthcare Diagnostics Inc.
- MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 by Branan Medical Corp.
- AMEDITECH DRUGSMARTCUP by AMEDITECH INC.
- DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY by Technicon Instruments Corp.
- ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT by Roche Diagnostic Systems, Inc.
- Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) by Hangzhou Alltest Biotech.Co.,Ltd.