FDA device listing
Instant-View TCA Urine Test (Cassette/Dip Strip),TCA Urine Test (Cassette/Dip Strip)
FDA device listing 1345660815 · ALFA SCIENTIFIC DESIGNS, INC.
Key facts
| Proprietary names | Instant-View TCA Urine Test (Cassette/Dip Strip),TCA Urine Test (Cassette/Dip Strip) |
|---|---|
| Owner/operator | ALFA SCIENTIFIC DESIGNS, INC. |
| Owner/operator number | 9034872 |
| Premarket submissions | K022693 |
| Product codes | MLK |
| Device names | MLK - Thin Layer Chromatography, Tricyclic Antidepressant Drugs |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3910 |
| Review panels | Clinical Toxicology |
| Registered establishments | ALFA SCIENTIFIC DESIGNS, INC. |
| Establishment registrations | 2060833 |
| FEI numbers | 3001452245 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 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