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Tissue-Tek Genie®
EUDAMEDFDA UDIClass C (EU MDR)
Ref 8364-C010Model Tissue-Tek Genie® anti-Cadherin 17 Rabbit Monoclonal Antibody [QR098] RTU, 10 capsules; 1 pack
Identity
- Trade Name
- Tissue-Tek Genie® EUDAMEDFDA UDI
- Generic Name
- Cadherin protein IVD, antibody FDA UDI
- Device Name
- Tissue-Tek Genie® anti-Cadherin 17 Rabbit MonoclonalAntibody [QR098] EUDAMEDanti-Cadherin 17 Rabbit Monoclonal Antibody [QR098], Ready-To-Use, 10 capsules/pack. FDA UDI
- Model / Reference
- Tissue-Tek Genie® anti-Cadherin 17 Rabbit Monoclonal Antibody [QR098] RTU, 10 capsules; 1 pack EUDAMED8364-C010 EUDAMEDFDA UDI
- Description
- anti-Cadherin 17 Rabbit Monoclonal Antibody [QR098], Ready-To-Use, 10 capsules/pack. FDA UDI
Identifiers
- Catalog Number
- 8364-C010 FDA UDI
- Primary DI / UDI-DI
- 00615233013965 EUDAMEDFDA UDI
- Basic UDI-DI
- 06152338300HV EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
- GMDN Term
- Cadherin protein IVD, antibody FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Tissue-Tek Genie® by Sakura Finetek USA, Inc — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 06152338300HV | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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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 (2)
- EUDAMED c4b44124-f99e-4dae-bdbb-105ab2262cd9 61 fields · synced May 31, 2026
- FDA UDI 8cf4a7a7-6743-4982-8abb-a8471f6ceff7 35 fields · synced May 26, 2026