FDA device listing
Platelia SARS COV 2 Total Ab
FDA device listing 1829529841 · Bio-Rad Laboratories (Bio-Rad Services France)
Key facts
| Proprietary names | Platelia SARS COV 2 Total Ab |
|---|---|
| Owner/operator | Bio-Rad Laboratories (Bio-Rad Services France) |
| Owner/operator number | 10078397 |
| Product codes | QKO |
| Device names | QKO - Reagent, Coronavirus Serological |
| Device class | Not classified |
| Classification regulations (21 CFR) | ORCA1.QKO |
| Review panels | Microbiology |
| Registered establishments | Bio-Rad Service France SAS |
| Establishment registrations | 3035708936 |
| FEI numbers | 3035708936 |
| Establishment operations | Foreign Exporter |
| 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