EUDAMED device
iSTATIS COVID-19 Ag HOME TEST
EUDAMED device 00686597200094 · bioLytical Laboratories Inc.
Key facts
| Primary DI | 00686597200094 |
|---|---|
| Trade name | iSTATIS COVID-19 Ag HOME TEST |
| Device name | iSTATIS COVID-19 Ag HOME TEST |
| Reference or catalog number | 90-1117 |
| Model | 90-1117 |
| Manufacturer | bioLytical Laboratories Inc. |
| Manufacturer SRN | CA-MF-000023304 |
| Risk class | IVD General |
| EMDN code | W0105040619 |
| EMDN description | CORONAVIRUS|CORONAVIRUS|CORONAVIRUS |
| Legislation | ivdd |
| Implantable | No |
| Sterile | No |
| Single use | Yes |
| Status date | May 26, 2022 |
At a glance
- No Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: