Identity
- Trade Name
- Epredia FDA UDI
- Generic Name
- Formalin substitute solution IVD FDA UDI
- Device Name
- Glyo-Fixx is formulated for use as a histological fixative, to replace formalin and zinc formalin for routine specimens as well as those intended for immunohistochemical or special staining procedures. It is also effective as a secondary fixative after unbuffered or buffered formalin or zinc formalin. FDA UDI
- Model / Reference
- Glyo-Fixx™ FDA UDI
- Description
- Glyo-Fixx is formulated for use as a histological fixative, to replace formalin and zinc formalin for routine specimens as well as those intended for immunohistochemical or special staining procedures. It is also effective as a secondary fixative after unbuffered or buffered formalin or zinc formalin. FDA UDI
Identifiers
- Catalog Number
- 9990920 FDA UDI
- Primary DI / UDI-DI
- 00673693236614 FDA UDI
- FDA Product Code
- IFL FDA UDI
- GMDN Term
- Formalin substitute solution 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
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: Formalin substitute solution IVD
Epredia by Richard-Allan Scientific LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Formalin substitute solution IVD.
- Epredia — Richard-Allan Scientific LLC · Class I
- Epredia — Richard-Allan Scientific LLC · 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
- Richard-Allan Scientific LLC
Sources (1)
- FDA UDI 7021c9bb-1162-40b2-a020-bb3b0c84753f 34 fields · synced Jun 8, 2026