Tissue-Tek Genie®
EUDAMEDFDA UDIClass C (EU MDR)
Identity
- Trade Name
- Tissue-Tek Genie® EUDAMEDFDA UDI
- Generic Name
- Special AT-rich sequence-binding protein 2 (SATB2) IVD, antibody FDA UDI
- Device Name
- Tissue-Tek Genie® anti-HER2 Rabbit Monoclonal Antibody [EP3] EUDAMEDTissue-Tek Genie® anti-SATB2 Rabbit Monoclonal Antibody [QR023] EUDAMEDanti-SATB2 Rabbit Monoclonal Antibody [QR023], 10 RTU capsules FDA UDI
- Model / Reference
- Tissue-Tek Genie® anti-HER2 Rabbit Monoclonal Antibody [EP3] EUDAMED8388-M250 EUDAMED8356-C010 EUDAMEDFDA UDI
- Description
- anti-SATB2 Rabbit Monoclonal Antibody [QR023], 10 RTU capsules FDA UDI
Identifiers
- Catalog Number
- 8356-C010 FDA UDI
- Primary DI / UDI-DI
- 00615233010582 EUDAMED00615233011350 EUDAMEDFDA UDI
- Basic UDI-DI
- 06152338271JF EUDAMED06152338291JM EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
- GMDN Term
- Special AT-rich sequence-binding protein 2 (SATB2) 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
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 | 06152338271JF | 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 (3)
- EUDAMED e9eedc11-e9b2-46bd-888c-d3f0eac4a662 61 fields · synced Aug 1, 2026
- EUDAMED 105ec727-5808-40bf-8924-c3dd4e23c8a5 61 fields · synced May 19, 2026
- FDA UDI 14a76986-7935-48ae-a62c-88b99264d431 35 fields · synced May 30, 2026