Epredia
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Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693090469
- Version / Model
- Reticulocyte Stain
- Catalog Number
- 89029
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-05
- Public Version
- 1
- Public Version Date
- 2024-09-13
- Public Version Status
- New
- Public Device Record Key
- bba057e0-94db-4f3f-9ffe-f469105a5b68
Device Description
In 1949, Dr. George Brecher developed a stain called new methylene blue to identify immature erythrocytes (reticulocytes) based upon aggregations of RNA within disintegrating ribosomes. This RNA is at its highest level immediately after enucleation of the cell and continues to decrease until its complete absence in the fully mature erythrocyte. Reticulocytes are so named due to their mesh-like (reticular) network of ribosomal RNA which, after staining, is readily visible with a blue granulofilamentous appearance. The quantitative evaluation of reticulocytes in peripheral blood is an important test used in the assessment of erythropoiesis, bone marrow function, and anemia typing.
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 |
|---|---|---|---|---|
| GJH | Stain, Reticulocyte | 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 | 00673693090469 | GS1 |