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 Zhejiang (2), Shandong (1), Hubei (1).
Record
Regulatory record for Epredia | Listed by | Richard-Allan Scientific LLC, United States |
| FDA product code | HZJ |
| Device type | Stain, Papanicolau |
| Device class | Class 1 |
| Regulation | 21 CFR 864.1850 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-09 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2024-08-09 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
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.