Epredia
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693069717
- Version / Model
- Three-Step Solution B
- Catalog Number
- 3323
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-23
- Public Version
- 1
- Public Version Date
- 2024-09-02
- Public Version Status
- New
- Public Device Record Key
- 91a68916-e72e-4919-b2b2-88e1571c680f
Device Description
The Three-Step Stain Set is comprised of three components: a methanol fixative (Fixative), an aqueous eosin solution (Solution A), and an aqueous methylene blue/azure A solution (Solution B). The staining solutions consist of xanthene and thiazine dyes, exhibiting both anionic and cationic properties, respectively. Cationic cellular components, such as erythrocytes and eosinophilic granules, share an affinity for the anionic dye of Solution A. The negatively charged phosphate groups of DNA and basophilic granules of the cytoplasm have an affinity for the polychromatic cationic dyes of Solution B. The aqueous stain formulations function to dissociate and activate the dye ions, allowing them to chemically bond with specific cellular components. When staining blood and bone marrow smears, the pH of the staining solutions is a critical factor
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 |
|---|---|---|---|---|
| HYF | Giemsa Stain | 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 | 00673693069717 | GS1 |