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RNAscope™ ISH Probe UBC (Positive Control)
EUDAMEDClass IVD General (EU MDR)
Ref 200460
Identity
- Trade Name
- RNAscope™ ISH Probe UBC (Positive Control) EUDAMED
- Device Name
- RNAscope™ ISH Probe UBC (Positive Control) EUDAMED
- Model / Reference
- 200460 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-200460LP EUDAMED
- Basic UDI-DI
- B-200460LP EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER 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
RNAscope™ ISH Probe UBC (Positive Control) by Advanced Cell Diagnostics — 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-200460LP | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Advanced Cell Diagnostics
- EUDAMED SRN
- US-MF-000047789
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED e5b56297-9d98-4cc5-9f14-164303928753 61 fields · synced Jun 19, 2026