Identity
- Trade Name
- Tissue-Tek Genie® FITC anti-IgG Goat Polyclonal Antibody EUDAMEDTissue-Tek Genie® FDA UDI
- Generic Name
- Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD FDA UDI
- Device Name
- Tissue-Tek Genie® FITC anti-IgG Goat Polyclonal Antibody EUDAMEDFITC anti-IgG Goat Polyclonal Antibody, 10 RTU capsules FDA UDI
- Model / Reference
- 8535-C010 EUDAMEDFDA UDI
- Description
- FITC anti-IgG Goat Polyclonal Antibody, 10 RTU capsules FDA UDI
Identifiers
- Catalog Number
- 8535-C010 FDA UDI
- Primary DI / UDI-DI
- 00615233002303 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00615233002303 EUDAMED
- FDA Product Code
- NJT FDA UDI
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
- GMDN Term
- Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD FDA UDI
Classification
- Device Class
- Class IVD General 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
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: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Tissue-Tek Genie® by Sakura Finetek USA, Inc — Class I — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sakura Finetek USA, Inc
Sources (2)
- FDA UDI bedd962e-f9fd-4541-82fa-f90f534d034b 35 fields · synced Oct 8, 2026
- EUDAMED 359f91b1-1a99-4686-945c-b6222a8cb0ab 61 fields · synced Oct 8, 2026