FDA device listing
ALCOGRAD,ALCOLOCK GR,ALCOLOCK LR,ALCOLOCK V3,ALCOLOCK WR3,ALCOSIM,ALERT J4X,ALERT J5,Certified Reference Material…
FDA device listing 1410272139 · ALCOHOL COUNTERMEASURE SYSTEMS CORP.
Key facts
| Proprietary names | ALCOGRAD,ALCOLOCK GR,ALCOLOCK LR,ALCOLOCK V3,ALCOLOCK WR3,ALCOSIM,ALERT J4X,ALERT J5,Certified Reference Material (ARS),DRIVESAFE exec,DRIVESAFE express,DRUGWIPE 1A,DRUGWIPE 5A,DRUGWIPE 5S,DRUGWIPE 6S,RELIANT EMU,TEST AND DRIVE,WIPEALYSER |
|---|---|
| Owner/operator | ALCOHOL COUNTERMEASURE SYSTEMS CORP. |
| Owner/operator number | 9005443 |
| Product codes | DJZ |
| Device names | DJZ - Devices, Breath Trapping, Alcohol |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.3050 |
| Review panels | Clinical Toxicology |
| Registered establishments | ALCOHOL COUNTERMEASURE SYSTEMS CORP. |
| Establishment registrations | 3003483691 |
| FEI numbers | 3003483691 |
| Establishment operations | Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database