Epredia
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693202244
- Version / Model
- Oxalic Acid Solution (1%)
- Catalog Number
- 88045
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-06
- Public Version
- 1
- Public Version Date
- 2024-09-16
- Public Version Status
- New
- Public Device Record Key
- dc02f1d8-9333-443f-8926-d4c6a976c122
Device Description
Potassium Permanganate Solution is the oxidizing agent in this technique. It is followed by an Oxalic Acid Solution to remove the excess permanganate. This step serves to enhance the subsequent staining of the reticular fibers. A sensitizing step using Ferric Ammonium Sulfate Solution impregnates the fibers, creating a metal-organic bond that is replaced by silver during subsequent treatment with Working Ammoniacal Silver Solution. To develop the visible silver, a Reducing Solution of dilute formaldehyde is used. The tissue structures that have been impregnated with the silver solution will now appear brown to black. Gold Chloride Solution is used to “tone” the sections, producing better contrast and clarity as the gold reacts and combines with the reduced silver. Unreduced silver is removed via treatment with Sodium Thiosulfate Solution. An optional nuclear fast red counterstain provides background staining as well as nuclear detail.
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 |
|---|---|---|---|---|
| LED | Stains, Chemical Solution | Hematology | 864.1850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43587 | Biological stain IVD | A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00673693202244 | GS1 |