Epredia
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693101141
- Version / Model
- Isopropyl Alcohol
- Catalog Number
- 9511
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-28
- Public Version
- 1
- Public Version Date
- 2024-08-05
- Public Version Status
- New
- Public Device Record Key
- a7263b59-e7ce-4c78-a98f-12464a722e37
Device 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
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PPM | General Purpose Reagent | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 55666 | Isopropanol alcohol IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of isopropanol alcohol in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693101141 | GS1 |