FDA device listing
AMP One Step Amphetamine Single Drug Test (Urine),BIO-RAD TOX/See Drug Screen Test-AMP,CERTUM AMP One Step Amphetamine…
FDA device listing 1405708058 · ABBOTT LABORATORIES
Key facts
| Proprietary names | AMP One Step Amphetamine Single Drug Test (Urine),BIO-RAD TOX/See Drug Screen Test-AMP,CERTUM AMP One Step Amphetamine Test Strip,iCassette™ Urine Test Drug Screen Cassette,iScreen™ Urine Test Drug Screen Dip Card,SureStep™ Urine Test Drug Screen Cassette, Amphetamine (AMP 1000),SureStep™ Urine Test Drug Screen Strip,SureStep™ Urine Test Drug Screen Strip, Amphetamine (AMP 1000) |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Premarket submissions | K011673 |
| Product codes | DKZ |
| Device names | DKZ - Enzyme Immunoassay, Amphetamine |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3100 |
| Review panels | Clinical Toxicology |
| Registered establishments | ABON BIOPHARM (HANGZHOU) CO., LTD., Alere San Diego, Inc. |
| Establishment registrations | 2027969, 3005641941 |
| FEI numbers | 1000125596, 3005641941 |
| Establishment operations | Contract Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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