Identity
- Trade Name
- LeukoStrat CDx FLT3 Mutation Assay EUDAMED
- Generic Name
- TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
- Device Name
- LeukoStrat CDx FLT3 Mutation Assay EUDAMED
- Model / Reference
- K4120431 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810022732595 EUDAMED
- Basic UDI-DI
- 081002273K41204314J EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Legislation / Framework
- IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices) EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
LeukoStrat CDx FLT3 Mutation Assay by Invivoscribe, Inc. (tests for acquired genetic or chromosomal alterations - other) — Class C — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 081002273K41204314J | Class C | Active |
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Manufacturer
- Manufacturer
- Invivoscribe, Inc.
- EUDAMED SRN
- US-MF-000011736
- Authorised Representative
- IN VIVOSCRIBE TECHNOLOGIES FR-AR-000003774
Sources (1)
- EUDAMED 68 fields · synced May 23, 2026