Leica Biosystems
ST Infinity H&E Staining System
3manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (1), Shandong (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| 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 | HYJ |
| Device type | Hematoxylin |
| 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 | 2024-12-16 |
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 | Per pack | Status |
|---|---|---|---|
| 000000000003801576 | In distribution | ||
| 000000000003801575 | 4 | In distribution | |
| 000000000003801540 | In distribution | ||
| 000000000003801698 | In distribution | ||
| 000000000003801500 | In distribution | ||
| 000000000003801570 | In distribution | ||
| 000000000003801571 | 4 | In distribution | |
| 000000000003802098 | In distribution | ||
| 000000000003801520 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Richard-Allan Scientific LLC | 23 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 6 |
| Pink Hematoxylin Counterstainer | BIO SB, Inc. | 5 |
| Hematoxylin Counterstainer | BIO SB, Inc. | 5 |
| TintoHematoxylin Automation | BIO SB, Inc. | 5 |
| CAT Hematoxylin | Biocare Medical, LLC | 3 |
| Contrast Hematolxylin HDH3 | Vitro SA | 2 |
| Tacha’s Automated Hematoxylin | Biocare Medical, LLC | 1 |
| Tacha’s Bluing Solution 10X | Biocare Medical, LLC | 1 |
| Ventana HE 600 Hematoxylin | Ventana Medical Systems, Inc. | 1 |
| Tacha’s Bluing Solution | Biocare Medical, LLC | 1 |
| Hematoxylin | Ventana Medical Systems, Inc. | 1 |
Showing 12 of 16. All products under Hematoxylin
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.