FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693089821
·
Model: Weigert's Iron Hematoxylin Part B
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693089821
- Version / Model
- Weigert's Iron Hematoxylin Part B
- Catalog Number
- 88029
- Company Name
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Labeler DUNS
- 929504710
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-04
- Public Version
- 1
- Public Version Date
- 2024-09-12
- Public Version Status
- New
- Public Device Record Key
- bdad729a-4f23-40a4-a526-003b32159f6a
Device Description
Gomori’s Trichrome Stain Kit Blue Collagen and its components are used as a special stain kit to distinguish between collagen and muscle fibers. The cytoplasmic stain and the collagen stain are combined into one solution along with phosphotungstic- phosphomolybdic and glacial acetic acids. Muscle cells and cytoplasm favor the red dyes, and this is facilitated by the phosphotungstic acid. Collagen fibers take up the tungstate ion, allowing for the blue dye to selectively bind.
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 |
|---|---|---|---|---|
| HYJ | Hematoxylin | 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 | 00673693089821 | GS1 |