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Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antib…
EUDAMEDFDA UDIClass C (EU MDR)
Ref 8337-M250Model Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14]
Identity
- Trade Name
- Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14] EUDAMEDTissue-Tek Genie® FDA UDI
- Generic Name
- Epithelial cell adhesion molecule (EpCAM) IVD, antibody FDA UDI
- Device Name
- Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14] EUDAMEDanti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14], 1 RTU cartridge FDA UDI
- Model / Reference
- Tissue-Tek Genie® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14] EUDAMED8337-M250 EUDAMEDFDA UDI
- Description
- anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antibody [BS14], 1 RTU cartridge FDA UDI
Identifiers
- Catalog Number
- 8337-M250 FDA UDI
- Primary DI / UDI-DI
- 00615233011312 EUDAMEDFDA UDI
- Basic UDI-DI
- 06152338304J5 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
- GMDN Term
- Epithelial cell adhesion molecule (EpCAM) 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
No
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® anti-Epithelial Cell Adhesion Molecule Mouse Monoclonal Antib… by Sakura Finetek USA, Inc — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA…
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 | 06152338304J5 | 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 59fe44ee-bdf5-404f-ada9-88e62af60e3c 61 fields · synced Jun 18, 2026
- FDA UDI 3f04b21e-2da9-4fb7-b661-10f3895f6bea 35 fields · synced May 30, 2026