FDA device listing
Omega Laboratories Hair Drug Screening Assay
FDA device listing 1927912562 · OMEGA LABORATORIES, INC.
Key facts
| Proprietary names | Omega Laboratories Hair Drug Screening Assay |
|---|---|
| Owner/operator | OMEGA LABORATORIES, INC. |
| Owner/operator number | 9074072 |
| Premarket submissions | K131181 |
| Product codes | LCM |
| Device names | LCM - Enzyme Immunoassay, Phencyclidine |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.LCM |
| Review panels | Clinical Toxicology |
| Registered establishments | OMEGA LABORATORIES, INC. |
| Establishment registrations | 3004847291 |
| FEI numbers | 3004847291 |
| Establishment operations | Manufacturer |
| 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