Leica Biosystems
HistoCore SPECTRA H&E Staining System S1-800
1manufacturer
6catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B&E BIO-Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 9 |
Record
| Listed by | Leica Biosystems Richmond, Inc., United States |
|---|---|
| FDA product code | LEE |
| Device type | Stains, Dye Solution |
| 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 | 2025-04-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3801659 | In distribution | |
| 3801658 | In distribution | |
| 3801656 | In distribution | |
| 000000000003801654 | In distribution | |
| 3801655 | In distribution | |
| 3801657 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Richard-Allan Scientific LLC | 28 |
| BD Cytology Stain Kit | Becton, Dickinson AND Company | 2 |
| Beckmancoulter | Immunotech Corp. | 1 |
| BD Non-GYN Stain Kit | Becton, Dickinson AND Company | 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.