Tissue-Tek Genie®
EUDAMEDFDA UDIClass C (EU MDR)
Identity
- Trade Name
- Tissue-Tek Genie® EUDAMEDFDA UDI
- Generic Name
- CD3 cell marker IVD, kit, enzyme immunohistochemistry FDA UDI
- Device Name
- Tissue-Tek Genie® anti-CD3 Rabbit Monoclonal Antibody [EP177] EUDAMEDanti-CD3 Rabbit Monoclonal Antibody [EP177], 10 RTU capsules FDA UDI
- Model / Reference
- Tissue-Tek Genie® anti-CD3 Rabbit Monoclonal Antibody [EP177] EUDAMED8280-C010 EUDAMEDFDA UDI
- Description
- anti-CD3 Rabbit Monoclonal Antibody [EP177], 10 RTU capsules FDA UDI
Identifiers
- Catalog Number
- 8280-C010 FDA UDI
- Primary DI / UDI-DI
- 00615233000996 EUDAMEDFDA UDI
- Basic UDI-DI
- 06152338223J4 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
- GMDN Term
- CD3 cell marker IVD, kit, enzyme immunohistochemistry 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
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
Tissue-Tek Genie® by Sakura Finetek USA, Inc — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Preferentially expressed antigen in melanoma (PRAME) IVD, antibody.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 06152338223J4 | 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 eb1c67e6-4e7b-4370-9c91-cd75608ef598 61 fields · synced May 30, 2026
- FDA UDI a54c85f1-41bb-4f76-abd7-21a8556a5203 35 fields · synced May 30, 2026