FDA device listing
Easy@Home Multi-Drug Urine Test Cup,Easy@Home Multi-Drug Urine Test Panel,Multi-Drug Urine Test Cup, Multi-Drug Urine…
FDA device listing 1484884306 · GUANGZHOU WONDFO BIOTECH CO., LTD.
Key facts
| Proprietary names | Easy@Home Multi-Drug Urine Test Cup,Easy@Home Multi-Drug Urine Test Panel,Multi-Drug Urine Test Cup, Multi-Drug Urine Test Panel |
|---|---|
| Owner/operator | GUANGZHOU WONDFO BIOTECH CO., LTD. |
| Owner/operator number | 9064561 |
| Premarket submissions | K130665 |
| Product codes | DIO, DIS, DJG, DKZ, JXM, LAF, LCM, LDJ |
| Device names | DIO - Enzyme Immunoassay, Cocaine And Cocaine Metabolites, DIS - Enzyme Immunoassay, Barbiturate, DJG - Enzyme Immunoassay, Opiates, DKZ - Enzyme Immunoassay, Amphetamine, JXM - Enzyme Immunoassay, Benzodiazepine, LAF - Gas Chromatography, Methamphetamine, LCM - Enzyme Immunoassay, Phencyclidine, LDJ - Enzyme Immunoassay, Cannabinoids |
| Device class | Class II, Unclassified |
| Classification regulations (21 CFR) | 862.3100, 862.3150, 862.3170, 862.3250, 862.3610, 862.3650, 862.3870, ORCA1.LCM |
| Review panels | Clinical Toxicology |
| Registered establishments | GUANGZHOU WONDFO BIOTECH CO., LTD. |
| Establishment registrations | 3004635103, 3023322455 |
| FEI numbers | 3004635103, 3023322455 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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