Epredia

The Amyloid Stain kit is a special stain technique to identify amyloid in tissue sections. Amyloid, a fiber-like protein, can be stained with Congo Red solution. Sodium Hydroxide is added…

Registry build 21.09.26

The Amyloid Stain kit is a special stain technique to identify amyloid in tissue sections. Amyloid, a fiber-like protein, can be stained with Congo Red solution. Sodium Hydroxide is added to the solution to break down hydrogen bonds between adjacent amyloid fibers allowing more bonding sites for the Congo Red. A light counterstain with Mayer’s hematoxylin allows contrast. Amyloid can be best detected by the use of green birefringence under a polarized lens of a light microscope. Care should be taken to section tissue sections at a thickness of 7-10 microns for optimal staining.

2manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

All of them in Jiangsu.

Chinese manufacturers registered for FDA product code HYL
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

Record

Regulatory record for Epredia
Listed by Richard-Allan Scientific LLC, United States
FDA product code HYL
Device type Hematoxylin Mayer’S
Device class Class 1
Regulation 21 CFR 864.1850
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-08-23

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Epredia
Catalogue number Size Status
Modified Mayer’s Hematoxylin In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Thermo Scientific Richard-Allan Scientific LLC 2

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.

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