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Dr. PCR™ BCR-ABL1 Major IS Detection Kit
EUDAMEDClass IVD General (EU MDR)
Ref DON01-X
Identity
- Trade Name
- Dr. PCR™ BCR-ABL1 Major IS Detection Kit EUDAMED
- Device Name
- Dr. PCR™ BCR-ABL1 Major IS Detection Kit EUDAMED
- Model / Reference
- DON01-X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809740940087 EUDAMED
- Basic UDI-DI
- B-08809740940087 EUDAMED
- EMDN Code
- W01060208 T (9;22) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
Yes
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
Dr. PCR™ BCR-ABL1 Major IS Detection Kit by OPTOLANE Technologies Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-08809740940087 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- OPTOLANE Technologies Inc.
- EUDAMED SRN
- KR-MF-000026042
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 6253d6c1-e1e3-4437-b754-dd6e9d743c46 61 fields · synced Jun 19, 2026