Epredia
- Primary DI
- 00673693088367
- Brand
- Epredia
- Company
- RICHARD-ALLAN SCIENTIFIC COMPANY
- Model
- EA-65 Papanicolaou Stain
- Catalog number
- 75604
- Device description
- EA-36, -50, -65 and Modified EA are ready-to-use cytoplasmic counterstains used for gynecological and non-gynecological cytology specimens. These products contain common dyes and reagent solvents used in traditional EA formulations. A well-preserved or fixed slide with adequate exposure to 95% alcohol or a commercial spray fixative is highly recommended for optimal staining results. Cellular results are traditional as well, with basal or intermediate cells staining a blue-green hue and surface cells staining a pink-red hue. This multicolored effect is due to dye uptake by various cells and their affinities for the specific dyes. EA-65 is used in conjunction with OG-6 for the staining of non-gynecological specimens. This formulation contains less dye resulting in lighter staining of highly mucoid sample types common in non-gynecological cytology.
- Published
- 2024-08-09
- 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 |
|---|
| HZJ | Stain, Papanicolau |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| HZJ | Stain, Papanicolau | Hematology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00673693088367 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00673693088367 | 00673693088367 | 673693088367 | 0673693088367 |
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
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|---|
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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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