FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 00673693202145
·
Model: Alcian Blue pH 2.5 Stain Solution
·
RICHARD-ALLAN SCIENTIFIC COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693202145
- Version / Model
- Alcian Blue pH 2.5 Stain Solution
- Catalog Number
- 88043
- 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
- fb3403ea-5599-4ea0-830f-5437455e4659
Device Description
"Alcian Blue reacts to compounds containing anionic groups such as acid mucosubstances and acid mucins. At pH 2.5, both carboxylated and sulfated acid mucosubstances are stained blue. Periodic acid is used to oxidize the tissue to form aldehyde groups that are demonstrated by Schiff Reagent. Glycogen and neutral mucosubstances as well as basement membranes will be stained magenta by Schiff Reagent, followed by a tap water rinse to develop and intensify its magenta hues. An optional counterstain may be used to provide nuclear detail. Hematoxylin 7211 is recommended; however, Kernechtrot Nuclear Fast Red may be used if a red nuclear stain is desired"
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 |
|---|---|---|---|---|
| LEE | Stains, Dye Solution | 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 | 00673693202145 | GS1 |