Epredia
- Primary DI
- 00673693089388
- Brand
- Epredia
- Company
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Model
- Alcoholic Hematoxylin Solution
- Catalog number
- 88007
- Device description
- "Elastic Stain Kit and its components are used as a special stain kit to identify elastic fibers. The elastic fibers stain black due to the dye lake created by the hematoxylin, ferric chloride and iodine mixture. The fibers are overstained and then differentiated with ferric chloride to break the dye-lake complex. To ensure fibers are not over-differentiated, slides should be examined during this step under the microscope. Elastic fibers will be stained black and sharply defined. The Van Gieson solution then counterstains the tissue with collagen staining red and other tissue structures, yellow. The Van Gieson solution will also remove some of the elastic fiber staining so the knowledge of a professional is required for adequate use. After staining, care should be taken in choosing a compatible mounting medium as some mountants can leach the picric acid from the Van Gieson counterstain."
- Published
- 2024-08-27
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| LEE | Stains, Dye Solution |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LEE | Stains, Dye Solution | Hematology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00673693089388 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00673693089388 | 00673693089388 | 673693089388 | 0673693089388 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Regulatory Flags
- DUNS number
- 929504710
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00673693181723 | Epredia | Pen-Fix™ | 6105 | 2024-11-19 |
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| 00673693063500 | Epredia | Microtome Knife, 16 CM, C | 152020 | 2024-10-29 |
| 00673693063753 | Epredia | Microtome Knife, 30CM, C | 152050 | 2024-10-29 |
| 00673693063760 | Epredia | Microtome Knife, 12 CM, D | 152060 | 2024-10-29 |
| 00673693063777 | Epredia | Microtome Knife, 16 CM, D | 152070 | 2024-10-29 |
| 00673693063784 | Epredia | Microtome Knife, 22 CM, D | 152080 | 2024-10-29 |
| 00673693063791 | Epredia | Microtome Knife, 25 CM, D | 152090 | 2024-10-29 |
| 00673693063807 | Epredia | Microtome Knife, 30 CM, D | 152100 | 2024-10-29 |
| 00673693063814 | Epredia | Tungsten Carbide Knife, 16 CM | 152120 | 2024-10-29 |
| 00673693064200 | Epredia | Adamas Blades for Disposable Magnetic Blade Carrie | 160010 | 2024-10-29 |
| 00673693064231 | Epredia | Adamas Blades for Disposable Magnetic Blade Carrie | 160040 | 2024-10-29 |
| 00673693226707 | Epredia | Tungsten Carbide D-Profile Microtome Knives | 5601006 | 2024-10-29 |
| 00673693263177 | Epredia | Microtome Knife D-Profile 240 mm | 2222006 | 2024-10-29 |
| 00673693568074 | Epredia | HistoPlast IM | 8331K | 2024-10-29 |
| 00673693220514 | Epredia | Microtome Knife C-Profile 240 mm | 2222005 | 2024-10-28 |
| 00673693232913 | Epredia | Stainless-Steel Microtome Knives 12.5 cm | 7619 | 2024-10-28 |
| 00673693233149 | Epredia | Standard Microtome Knife 125 mm | 7702 | 2024-10-28 |
| 00673693233187 | Epredia | Standard Microtome Knife 250 mm | 7704 | 2024-10-28 |
| 00673693233200 | Epredia | Stainless-Steel Microtome Knives 18.5 cm | 7719 | 2024-10-28 |
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