Hematoxylin

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Guangdong, Shandong and Zhejiang: 3 hold an FDA registration.

Jinan Babio Biotechnology Co., Ltd. Shandong
Shenzhen Dakewe BIO-Engineering Co., Ltd. Guangdong
Zhejiang Gene Science Co., Ltd. Zhejiang

What Is FDA Product Code HYJ?

Hematoxylin is FDA product code HYJ, Class 1, 21 CFR 864.1850.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2017. None was by a company in China. 1 is Class I, the most serious grade.

The root cause the FDA records most often is Process control (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Oncore Pro Hematoxylin

Catalogue number OPRI6087T60, listed by Biocare Medical, LLC, United States, under Hematoxylin. 3 manufacturers in China are registered for this product code.

Hematoxylin II

Catalogue number 05277965001, listed by Ventana Medical Systems, Inc., United States, under Hematoxylin. 3 manufacturers in China are registered for this product code.

Elastic Stain Core Kit

Catalogue number 09185984001, listed by Ventana Medical Systems, Inc., United States, under Hematoxylin. 3 manufacturers in China are registered for this product code.

BioSci™

Hematoxylin Staining Solution

Hematoxylin

Catalogue number 05266726001, listed by Ventana Medical Systems, Inc., United States, under Hematoxylin. 3 manufacturers in China are registered for this product code.

Tacha’s Bluing Solution

Catalogue number HTBLU-M, listed by Biocare Medical, LLC, United States, under Hematoxylin. 3 manufacturers in China are registered for this product code.

Contrast Hematolxylin HDH3

2 catalogue numbers from MAD-HDH3-100VS, listed by Vitro SA, under Hematoxylin. 3 manufacturers in China are registered for this product code.

Ventana HE 600 Hematoxylin

Catalogue number 07024282001, listed by Ventana Medical Systems, Inc., United States, under Hematoxylin. 3 manufacturers in China are registered for this product code.

Leica Biosystems

ST Infinity H&E Staining System

Fisherbrand

Pinnacle 2 Hematoxylin 4X500ML

CAT Hematoxylin

3 catalogue numbers from CATHE-GL, listed by Biocare Medical, LLC, United States, under Hematoxylin. 3 manufacturers in China are registered for this product code.

Tacha’s Bluing Solution 10x

Catalogue number HTBLU-MX, listed by Biocare Medical, LLC, United States, under Hematoxylin. 3 manufacturers in China are registered for this product code.

Tacha’s Automated Hematoxylin

Catalogue number NM-HEM-M, listed by Biocare Medical, LLC, United States, under Hematoxylin. 3 manufacturers in China are registered for this product code.

TintoHematoxylin Automation

Hematoxylin Counterstainer provides a nuclear blue counterstain for Immunocytochemical, Immunohistochemical and CISH procedures.

Hematoxylin Counterstainer

Hematoxylin Counterstainer provides a nuclear blue counterstain for Immunocytochemical, Immunohistochemical and CISH procedures.

Epredia

Hematoxylin 7211 is a rapid, progressive hematoxylin. The product is a hybrid between classical Harris and Gill formulations: it provides the classic intensity and hues of a Harris…

Pink Hematoxylin Counterstainer

Pink Hematoxylin Counterstainer provides a nuclear pink counterstain for Immunocytochemical, Immunohistochemical and CISH procedures.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer