FDA device listing
Siro Diagnostics COVID-19 Molecular Test
FDA device listing 1340631539 · Siro Diagnostics, Inc.
Key facts
| Proprietary names | Siro Diagnostics COVID-19 Molecular Test |
|---|---|
| Owner/operator | Siro Diagnostics, Inc. |
| Owner/operator number | 10092299 |
| Premarket submissions | DEN220028 |
| Product codes | QWB |
| Device names | QWB - Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3984 |
| Review panels | Microbiology |
| Registered establishments | Siro Diagnostics, Inc. |
| Establishment registrations | 3034617817 |
| FEI numbers | 3034617817 |
| Establishment operations | 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