Epredia
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…
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 50 is used in conjunction with OG-6 for the staining of gynecological specimens. It will provide a very traditional staining result with common staining hues and intensities. EA-50 can also be used for non-gynecological specimens however, although EA-65 is recommended.
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
Record
| Listed by | Richard-Allan Scientific LLC, United States |
|---|---|
| FDA product code | KZJ |
| Device type | Device, Gas Generating |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2580 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EA-50 Papanicolaou Stain | In distribution |
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| BD GasPak™ EZ CO2 Container System Sachets | Becton, Dickinson AND Company | 1 |
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| Advanced Instruments Standard Anoxomat Jar, Large | Advanced Instruments, LLC | 1 |
| Advanced Instruments Standard Anoxomat Jar, Small | Advanced Instruments, LLC | 1 |
| BD BBL™ Bio-Bag™ Environmental Chamber Type A, Multi-Plate | Becton, Dickinson AND Company | 1 |
| Advanced Instruments Palladox Disposable Satchet | Advanced Instruments, LLC | 1 |
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Showing 12 of 48. All products under Device, Gas Generating
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.