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Leukemia M-BCR Fusion Gene Real Time RT-PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref TR-0126-08Ref TR-0126-04
Identity
- Trade Name
- Leukemia M-BCR Fusion Gene Real Time RT-PCR Kit EUDAMED
- Device Name
- Leukemia M-BCR Fusion Gene Real Time RT-PCR Kit EUDAMED
- Model / Reference
- TR-0126-08 EUDAMEDTR-0126-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971042228674 EUDAMED06971042228650 EUDAMED
- Basic UDI-DI
- B-06971042228674 EUDAMEDB-06971042228650 EUDAMED
- EMDN Code
- W0103080105 ANTIBODIES FOR SUBTYPING OF LEUKEMIA (EXCEPT B-&T-CELL TYPING) EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France 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
Leukemia M-BCR Fusion Gene Real Time RT-PCR Kit by Shanghai Zj Bio-Tech Co., Ltd. — 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-06971042228674 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Shanghai Zj Bio-Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000017861
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED cf4b2014-9ff9-42c8-9169-afae96287d0d 61 fields · synced Jul 24, 2026
- EUDAMED 976dc0ec-351e-4a68-bf4d-eeddfe1452cd 61 fields · synced May 18, 2026