Identity
- Trade Name
- Tissue-Tek Genie® FDA UDI
- Generic Name
- Immunoglobulin G subclass (IgG subclass) IVD, antibody FDA UDI
- Device Name
- anti-IgG4 Mouse Monoclonal Antibody [HP6025], 10 RTU capsules FDA UDI
- Model / Reference
- 8384-C010 FDA UDI
- Description
- anti-IgG4 Mouse Monoclonal Antibody [HP6025], 10 RTU capsules FDA UDI
Identifiers
- Catalog Number
- 8384-C010 FDA UDI
- Primary DI / UDI-DI
- 00615233008930 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Immunoglobulin G subclass (IgG subclass) IVD, antibody FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.1860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Immunoglobulin G subclass (IgG subclass) IVD, antibody
Tissue-Tek Genie® by Sakura Finetek USA, Inc — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Immunoglobulin G subclass (IgG subclass) IVD, antibody.
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- IgG4 (EP138) Rabbit Monoclonal Primary Antibody — CELL MARQUE CORPORATION · Class I
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | 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 e0da7233-4495-46cc-a456-b1d5245e3fde 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 29, 2026