Hematoxylin
Catalogue number 05266726001, listed by Ventana Medical Systems, Inc., United States, under Hematoxylin. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
1recall
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 | Ventana Medical Systems, Inc., United States |
|---|---|
| FDA product code | HYJ |
| Device type | Hematoxylin |
| Device class | Class 1 |
| Regulation | 21 CFR 864.1850 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-01-29 |
| Record revised | 2025-07-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05266726001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Richard-Allan Scientific LLC | 23 |
| Leica Biosystems | Leica Biosystems Richmond, Inc. | 9 |
| 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 |
Showing 12 of 16. All products under Hematoxylin
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-12-19 | Class I | Process control | Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II. | 71640 units | 2021-11-22 |
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.