Epredia
Basic Information
- Brand Name
- Epredia
- Primary DI
- 00673693090001
- Version / Model
- Crystal Violet Solution
- Catalog Number
- 88101
- 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
- bc441a5d-9bf7-4754-9fd2-6b9ffb5d981d
Device Description
"Gram Stain Kits – Tissue & Film Bacteria can be classified into one of two families based upon structural and compositional differences in their cell walls. Gram-positive bacteria have thick cell walls with high peptidoglycan content, whereas Gram-negative bacteria have thin cell walls with low peptidoglycan content. Both Gram-positive and Gram-negative bacteria stain with the dye- lake formed by Crystal Violet Solution and Gram’s Iodine Solution. However, during rinsing with Decolorizing Solution, this dye-lake is completely removed from the thin-walled Gram- negative bacteria, allowing them to be subsequently stained with Safranin O Stain Solution. The short duration of the decolorization step enables Gram-positive bacteria to retain the crystal violet dye-lake. Care should be taken when rinsing slides with Decolorizing Solution, as extended rinses can cause the crystal violet dye-lake to be removed from Gram-positive bacteria in addition to Gram-negative bacteria. Within the Tissue Kit only, tissue elements are then counterstained yellow by Tartrazine Stain Solution."
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 |
|---|---|---|---|---|
| ICF | Crystal Violet For Histology | 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 | 00673693090001 | GS1 |