Epredia

Modified Harris Hematoxylin is an acidified, ready-to-use formulation that provides traditional nuclear staining results. Harris hematoxylin procedures require acid alcohol differentiation.…

Registry build 21.09.26

Modified Harris Hematoxylin is an acidified, ready-to-use formulation that provides traditional nuclear staining results. Harris hematoxylin procedures require acid alcohol differentiation. The nuclear chromatin and cytoplasm are overstained and the acid alcohol is used to destain the cytoplasm and to remove excess stain from the nucleus. Staining times are typically in the 5-minute range. Epredia Differentiating Solution is recommended for use with Modified Harris Hematoxylin

2manufacturers in China registered for this device type
8catalogue numbers in this listing

Who Else Makes It

All of them in Jiangsu.

Chinese manufacturers registered for FDA product code HYK
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 HYK
Device type Hematoxylin Harris’S
Device class Class 1
Regulation 21 CFR 864.1850
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-09-04

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 Harris Hematoxylin (Series R) In distribution
Harris Hematoxylin Non-acidified (Series S) In distribution
Harris Hematoxylin Acidified (Series S) In distribution
Modified Harris Hematoxylin (Series R) In distribution
Harris Hematoxylin Acidified (Series S) In distribution
Modified Harris Hematoxylin (Series R) In distribution
Harris Hematoxylin Non-acidified (Series S) In distribution
Instant Hematoxylin (Series S) In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Leica Biosystems Leica Biosystems Richmond, Inc. 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