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Epredia

FDA UDI

Class I (US FDA UDI)

by Richard-Allan Scientific LLC

Identity

Trade Name
Epredia FDA UDI
Generic Name
Isopropanol alcohol IVD, reagent FDA UDI
Device Name
Dehydrant Alcohol product lines are specifically designed for tissue processing and staining of histological and cytological specimens. The products are a clear, colorless blend of ethyl, isopropyl, and methyl alcohol that in some cases have trace amounts of other denatured materials. All Dehydrant Alcohol products are non-controlled substances and do not require record keeping. The formulations are readily miscible with water to form any desired grade of alcohol and can be used with all clearing reagents. The Dehydrant Alcohol line can be used with both open and closed tissue processors. Protective gloves should be worn and work should be performed in a ventilated area. Dehydrant Alcohol is a flammable product and must be stored in a flammable fire cabinet. The Dehydrant Alcohol product line can also be used for hydrating and dehydrating tissue sections during staining. They can be used with all special stains that require dehydration, as solvents for preparing special stains, and immunohistochemical procedures that are compatible with alcoholic dehydrants. The Dehydrant Alcohol product line can be substituted in place of any alcohol you are presently using for hematoxylin and eosin-y staining. They are compatible with all manual procedures and automatic stainers. FDA UDI
Model / Reference
Methyl Alcohol FDA UDI
Description
Dehydrant Alcohol product lines are specifically designed for tissue processing and staining of histological and cytological specimens. The products are a clear, colorless blend of ethyl, isopropyl, and methyl alcohol that in some cases have trace amounts of other denatured materials. All Dehydrant Alcohol products are non-controlled substances and do not require record keeping. The formulations are readily miscible with water to form any desired grade of alcohol and can be used with all clearing reagents. The Dehydrant Alcohol line can be used with both open and closed tissue processors. Protective gloves should be worn and work should be performed in a ventilated area. Dehydrant Alcohol is a flammable product and must be stored in a flammable fire cabinet. The Dehydrant Alcohol product line can also be used for hydrating and dehydrating tissue sections during staining. They can be used with all special stains that require dehydration, as solvents for preparing special stains, and immunohistochemical procedures that are compatible with alcoholic dehydrants. The Dehydrant Alcohol product line can be substituted in place of any alcohol you are presently using for hematoxylin and eosin-y staining. They are compatible with all manual procedures and automatic stainers. FDA UDI

Identifiers

Catalog Number
9615 FDA UDI
Primary DI / UDI-DI
00673693101523 FDA UDI
FDA Product Code
PPM FDA UDI
GMDN Term
Isopropanol alcohol 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: Isopropanol alcohol IVD, reagent

Epredia by Richard-Allan Scientific LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Isopropanol alcohol IVD, reagent.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 062f3932-57a5-4226-86b6-c2409cc03250 34 fields · synced Jun 8, 2026