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Human JAK2 Gene V617F Mutation Detection Kit (Digital PCR Method)
EUDAMEDClass IVD General (EU MDR)
Ref 3.02.03.0006Model 96 Tests
Identity
- Trade Name
- Human JAK2 Gene V617F Mutation Detection Kit (Digital PCR Method) EUDAMED
- Device Name
- Human JAK2 Gene V617F Mutation Detection Kit (Digital PCR Method) EUDAMED
- Model / Reference
- 96 Tests EUDAMED3.02.03.0006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975760470179 EUDAMED
- Basic UDI-DI
- B-06975760470179 EUDAMED
- EMDN Code
- W01060299 TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain 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
Human JAK2 Gene V617F Mutation Detection Kit (Digital PCR Method) by Suzhou Precigenome Ltd, Co; — 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-06975760470179 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Suzhou Precigenome Ltd, Co;
- EUDAMED SRN
- CN-MF-000024105
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED ab64317f-fe91-4c0a-955a-d7daed48b505 61 fields · synced Jul 28, 2026