EUDAMED device
LeukoStrat CDx FLT3 Mutation Assay
EUDAMED device 00810022732595 · Invivoscribe, Inc.
Key facts
| Primary DI | 00810022732595 |
|---|---|
| Trade name | LeukoStrat CDx FLT3 Mutation Assay |
| Device name | LeukoStrat CDx FLT3 Mutation Assay |
| Reference or catalog number | K4120431 |
| Manufacturer | Invivoscribe, Inc. |
| Manufacturer SRN | US-MF-000011736 |
| Risk class | Class C |
| EMDN code | W01060299 |
| EMDN description | TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER |
| Legislation | ivdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Dec 16, 2025 |
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: