Identity
- Trade Name
- Tissue-Tek Genie® FDA UDI
- Generic Name
- Fibrinogen (Factor I) assay IVD, antibody FDA UDI
- Device Name
- FITC anti-Fibrinogen Goat Polyclonal Antibody, 10 RTU capsules FDA UDI
- Model / Reference
- 8538-C010 FDA UDI
- Description
- FITC anti-Fibrinogen Goat Polyclonal Antibody, 10 RTU capsules FDA UDI
Identifiers
- Catalog Number
- 8538-C010 FDA UDI
- Primary DI / UDI-DI
- 00615233002334 FDA UDI
- FDA Product Code
- NJT FDA UDI
- GMDN Term
- Fibrinogen (Factor I) assay 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: Fibrinogen (Factor I) assay IVD, antibody
Tissue-Tek Genie® by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fibrinogen (Factor I) assay IVD, antibody.
- Poly Rb A-Hu Fibrinogen — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class II
- FITC Anti-Fibrinogen Primary Antibody — Ventana Medical Systems · Class I
- IHC — Slmp, LLC · Class I
- Poly Rb A-Hu Fibrinogen/FITC — AGILENT TECHNOLOGIES SINGAPORE PTE LTD · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sakura Finetek USA, Inc
Sources (1)
- FDA UDI 27f130fe-00e7-4aff-ad97-c09ba9984b0d 35 fields · synced May 30, 2026