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LeukoStrat® NPM1 Mutation Assay Megakit - ABI Fluorescence Detection
EUDAMEDClass IVD General (EU MDR)
Ref 9-416-0001
Identity
- Trade Name
- LeukoStrat® NPM1 Mutation Assay Megakit - ABI Fluorescence Detection EUDAMED
- Device Name
- NPM1 Mutation Assay for ABI Fluorescence Detection EUDAMED
- Model / Reference
- 9-416-0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-08100227394160001STX8 EUDAMED
- Basic UDI-DI
- B-08100227394160001STX8 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
No
EUDAMED
Surgical Instrument
No
EUDAMED
LeukoStrat® NPM1 Mutation Assay Megakit - ABI Fluorescence Detection by Invivoscribe, Inc. — Class IVD General — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08100227394160001STX8 | Class IVD General | 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 ca0bc911-14d2-4fbb-bb91-29a934f647e4 61 fields · synced Jun 19, 2026