Epredia
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693228541
- Version / Model
- EA-65 Papanicolaou Stain
- Catalog Number
- 6766003
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-09
- Public Version
- 1
- Public Version Date
- 2024-08-19
- Public Version Status
- New
- Public Device Record Key
- 0583add8-4458-4564-92e6-f049e2f5b585
- Distribution End Date
- 2024-08-09
Device Description
EA-36, -50, -65 and Modified EA are ready-to-use cytoplasmic counterstains used for gynecological and non-gynecological cytology specimens. These products contain common dyes and reagent solvents used in traditional EA formulations. A well-preserved or fixed slide with adequate exposure to 95% alcohol or a commercial spray fixative is highly recommended for optimal staining results. Cellular results are traditional as well, with basal or intermediate cells staining a blue-green hue and surface cells staining a pink-red hue. This multicolored effect is due to dye uptake by various cells and their affinities for the specific dyes. EA-65 is used in conjunction with OG-6 for the staining of non-gynecological specimens. This formulation contains less dye resulting in lighter staining of highly mucoid sample types common in non-gynecological cytology.
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 |
|---|---|---|---|---|
| HZJ | Stain, Papanicolau | 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 | 00673693228541 | GS1 |