Identity
- Trade Name
- Epredia FDA UDI
- Generic Name
- Ethanol (ETOH) IVD, reagent FDA UDI
- Device Name
- Denatured Ethyl Alcohol is specifically designed for tissue processing and staining of histological and cytological specimens. The product is a clear, colorless reagent that is quality controlled. Denatured Ethyl Alcohol contains methyl alcohol, a known toxin. Precaution should be taken when handling Denatured Ethyl Alcohol. Protective gloves should be worn and work should be performed in a ventilated area. Denatured Ethyl Alcohol can be used with both open and closed tissue processors. It is also compatible with all manual staining procedures and automatic stainers. Denatured Ethyl Alcohol is a flammable product and must be stored in a flammable fire cabinet FDA UDI
- Model / Reference
- Denatured Ethanol High Purity FDA UDI
- Description
- Denatured Ethyl Alcohol is specifically designed for tissue processing and staining of histological and cytological specimens. The product is a clear, colorless reagent that is quality controlled. Denatured Ethyl Alcohol contains methyl alcohol, a known toxin. Precaution should be taken when handling Denatured Ethyl Alcohol. Protective gloves should be worn and work should be performed in a ventilated area. Denatured Ethyl Alcohol can be used with both open and closed tissue processors. It is also compatible with all manual staining procedures and automatic stainers. Denatured Ethyl Alcohol is a flammable product and must be stored in a flammable fire cabinet FDA UDI
Identifiers
- Catalog Number
- 9200-55 FDA UDI
- Primary DI / UDI-DI
- 00673693091688 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Ethanol (ETOH) IVD, reagent 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: Ethanol (ETOH) IVD, reagent
Epredia by Richard-Allan Scientific LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ethanol (ETOH) IVD, reagent.
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- VITROS — Ortho-Clinical Diagnostics · 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
- Richard-Allan Scientific LLC
Sources (1)
- FDA UDI 12967bf8-71da-4b1f-824a-847706a41c71 34 fields · synced Jun 8, 2026