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Tissue-Tek Genie® anti-INSM1 Rabbit Monoclonal Antibody [ZR395]
EUDAMEDClass C (EU MDR)
Ref 8379-C010Model Tissue-Tek Genie® anti-INSM1 Rabbit Monoclonal Antibody [ZR395]
Identity
- Trade Name
- Tissue-Tek Genie® anti-INSM1 Rabbit Monoclonal Antibody [ZR395] EUDAMED
- Device Name
- Tissue-Tek Genie® anti-INSM1 Rabbit Monoclonal Antibody [ZR395] EUDAMED
- Model / Reference
- Tissue-Tek Genie® anti-INSM1 Rabbit Monoclonal Antibody [ZR395] EUDAMED8379-C010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00615233014559 EUDAMED
- Basic UDI-DI
- 06152338309JF EUDAMED
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
New Device
No
EUDAMED
Tissue-Tek Genie® anti-INSM1 Rabbit Monoclonal Antibody [ZR395] by Sakura Finetek USA, Inc — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 06152338309JF | Class C | Active |
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Manufacturer
- Manufacturer
- Sakura Finetek USA, Inc
- EUDAMED SRN
- US-MF-000022208
- Authorised Representative
- Sakura Finetek Europe B.V. NL-AR-000007853
Sources (1)
- EUDAMED f480a844-fa93-4a43-b354-91d6e250a999 61 fields · synced Oct 6, 2026