FDA device listing
AP5020, ALCOCAM, AP037, AP601, AP602, AP203, AP147, AP205,Blood-Alcohol Tester: AP036, AP038, AP039, FiT240, FiT333…
FDA device listing 1322410584 · A&A Product Manufacturing Limited
Key facts
| Proprietary names | AP5020, ALCOCAM , AP037, AP601, AP602, AP203, AP147, AP205,Blood-Alcohol Tester: AP036, AP038, AP039, FiT240, FiT333, FiT032, FiT228-LC, AT230, AT229, FiT303, AT002, FiT088,Breath-Alcohol Tester: ALCOPATROL AP338, AP4020, AP8020, AP8080, AT007, AT010, AT011, AP012, AP013, AP015, AP018, AP035,,Breath-Alcohol Tester: FiT198, FiT148, FiT233 |
|---|---|
| Owner/operator | A&A Product Manufacturing Limited |
| Owner/operator number | 10056778 |
| 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 | A&A PRODUCT MANUFACTURING LIMITED |
| Establishment registrations | 3014302776 |
| FEI numbers | 3014302776 |
| Establishment operations | Contract Manufacturer, 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