FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693089623
·
Model: Biebrich Scarlet- Acid Fuchsin Solution
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693089623
- Version / Model
- Biebrich Scarlet- Acid Fuchsin Solution
- Catalog Number
- 88019
- 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
- 40ef01bf-31f9-43da-9696-1785756c166a
Device Description
Biebrich Scarlet-Acid Fuchsin is utilized to stain the acid substances such as the cytoplasm, muscle and collagen. Phosphotungstic-Phosphomolybdic (PTA-PMA) solution is then used to remove the Biebrich Scarlet from the collagen fibers. The cytoplasm will retain the stain due to its permeability. The Aniline Blue is then utilized to restain the decolorized collagen fibers. A 1% Acetic Acid solution may further be used to differentiate the stained tissue section
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 |
|---|---|---|---|---|
| ICN | Biebrich Scarlet | 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 | 00673693089623 | GS1 |