Epredia
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693089210
- Version / Model
- Methyl Green-Pyronin Y Stain Solution
- Catalog Number
- 87011
- 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
- a2b3ac58-2e90-401b-a689-e61196d79f91
Device Description
"Methyl Green-Pyronin-Y Stain Solution is intended for used in differentiating DNA and RNA in tissue sections for the diagnosis of general pathology specimens. The reaction is based upon the competition between the slow staining, but doubly charged, methyl green and the more rapidly staining, singly charged pyronin Y. Methyl green has two cationic charged groups that become linked to the phosphate moieties in the DNA. The pyronin Y displaces the methyl green from all sites of linkage except where its double charge gives it a selective advantage (acidic polymer such as DNA). Consequently, the methyl green stains DNA and retains its binding to this substance against the competitive action of pyronin Y. Pyronin Y stains the less polymerized RNA rapidly and displaces methyl green from linkages having smaller polymeric acidic substances (RNA). The reaction is done at pH 4.2 – pH 4.3. The advantage of a low pH is to have the nucleic acids in a charged condition and in their least soluble state."
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 |
|---|---|---|---|---|
| HZA | Methyl Green | 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 | 00673693089210 | GS1 |