Epredia
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Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693089180
- Version / Model
- Modified Grocott’s Methenamine Silver Stain Kit
- Catalog Number
- 87008
- 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
- 0de6860b-33ed-4ac7-8075-f8e9c6c645db
Device Description
"Fungal cell walls are rich in polysaccharides known as glucans. Periodic Acid Solution oxidizes these polysaccharides to form aldehydes, which in turn react with the silver ions present in the Working Methenamine Silver Solution and reduce them to form visible metallic silver. Gold Chloride Solution tones the sections and intensifies the reduced silver by forming a silver-gold complex. Sodium Thiosulfate Solution removes any unreduced silver from the tissue sections, followed by Fast Green Stain Solution which produces a light green background to further enhance contrast."
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| JTS | Stains, Microbiologic | 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 | 00673693089180 | GS1 |