Leica Biosystems
Alcoholic Eosin Y 515
4manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Shandong (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
| Shenzhen Dakewe BIO-Engineering Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
Record
| Listed by | Leica Biosystems Richmond, Inc., United States |
|---|---|
| FDA product code | HYB |
| Device type | Eosin Y |
| Device class | Class 1 |
| Regulation | 21 CFR 864.1850 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-12-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 000000000003801600 | In distribution | ||
| 000000000003801619 | 4 | In distribution | |
| 000000000003801606 | 4 | In distribution | |
| 000000000003803805 | In distribution | ||
| 000000000003801615 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Richard-Allan Scientific LLC | 14 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 1 |
| Edgar Degas Eosin | Biocare Medical, LLC | 1 |
| Rubens Eosin-Phloxine | Biocare Medical, LLC | 1 |
| BioSci™ | Shenzhen Dakewe BIO-Engineering Co., Ltd. | 1 |
| QwikCheck Vitality Kit | M.E.S. Medical Electronic Systems Ltd. | 1 |
| Ventana HE 600 Eosin | Ventana Medical Systems, Inc. | 1 |
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.