Identity
- Trade Name
- Tissue-Tek ClearFIX® FDA UDI
- Generic Name
- 10% Neutral buffered formalin IVD FDA UDI
- Device Name
- Buffered Formalin Fixative FDA UDI
- Model / Reference
- 5996 FDA UDI
- Description
- Buffered Formalin Fixative FDA UDI
Identifiers
- Catalog Number
- 5996 FDA UDI
- Primary DI / UDI-DI
- 10615233080186 FDA UDI
- FDA Product Code
- IFP FDA UDI
- GMDN Term
- 10% Neutral buffered formalin IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: 10% Neutral buffered formalin IVD
Tissue-Tek ClearFIX® by Sakura Finetek USA, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as 10% Neutral buffered formalin IVD.
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- Rowley Biochemical Neutral Buffered Formalin — Transene Company, Inc. · Class I
- O&P Collection Vials Formalin/C&S Kits — Medical Chemical Corporation · Class I
- Formalin / C&S / Clean Stool Collection Kits — Medical Chemical Corporation · Class I
- Z-PVA / Formalin / C&S / Clean O&P Collection Kits — Medical Chemical Corporation · Class I
- Total-Fix / Formalin / C&S / Clean O&P Collection Kits — Medical Chemical Corporation · Class I
- Tissue-Tek® — Sakura Finetek USA, Inc · Class I
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 00b63f55-d98e-4ee2-aef5-010a7b363b22 35 fields · synced Jun 8, 2026