FDA device listing
Genabio COVID-19 Rapid Self-Test Kit
FDA device listing 1470273776 · Hangzhou Laihe Biotech Co.,Ltd.
Key facts
| Proprietary names | Genabio COVID-19 Rapid Self-Test Kit |
|---|---|
| Owner/operator | Hangzhou Laihe Biotech Co.,Ltd. |
| Owner/operator number | 10065287 |
| Product codes | QKP |
| Device names | QKP - Coronavirus Antigen Detection Test System. |
| Device class | Not classified |
| Classification regulations (21 CFR) | ORCA1.QKP |
| Review panels | Microbiology |
| Registered establishments | HANGZHOU LAIHE BIOTECH CO.,LTD. |
| Establishment registrations | 3016610313 |
| FEI numbers | 3016610313 |
| Establishment operations | Contract 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