Epredia

"Hematology stains are typically mixtures of several thiazin dyes in a methanol solvent. Ionic and non-ionic forces are involved in the binding of the dyes. The negatively charged…

Registry build 21.09.26

“Hematology stains are typically mixtures of several thiazin dyes in a methanol solvent. Ionic and non-ionic forces are involved in the binding of the dyes. The negatively charged phosphoric acid groups of DNA attract the purple polychromatic cationic dyes to the nuclei. The blue basophilic granules are stained by the polychromatic cationic dyes. Cationic cellular components, such as the erythrocytes and eosinophilic granules, are stained by the red and pink anionic dyes. The buffers used in the staining procedure liberate and activate dye ions allowing them to chemically bond with specific cellular components. When staining blood and bone marrow smears, the pH of the staining solution and/or buffer is a critical factor. The Wright, Wright-Giemsa, Giemsa, May-Grunwald and Jenner stains all rely on a separate buffer solution to control the pH of the reaction, whereas the buffered versions are referred to as “one-step” and have the buffering component already in the staining solution. There are pros and cons to each type of hematology stain although they all contain the thiazin dyes which control the coloration of the nuclear cell components. The single solutions with buffer included generally present more precipitate and the cellular detail is not defined as well as using separate stain and buffer solutions. This kit contains three 500ml bottles of Wright Giemsa stain, pH 6.8 Buffer and a Rinse solution intended to be used as a system per the instructions for use.”

1manufacturer
20catalogue numbers in this listing
1recall

Who Else Makes It

Registered in Shandong.

Chinese manufacturers registered for FDA product code HYF
Manufacturer City Province Registered as Device types
Jinan Babio Biotechnology Co., Ltd. Jinan Shandong Manufacturer 25

Record

Regulatory record for Epredia
Listed by Richard-Allan Scientific LLC, United States
FDA product code HYF
Device type Giemsa Stain
Device class Class 1
Regulation 21 CFR 864.1850
Establishment Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-09-05

Specifications

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

Catalogue Numbers

Catalogue numbers for Epredia
Catalogue number Size Status
Giemsa Stain In distribution
Kwik-Diff™ Stain Kit In distribution
Wright Giemsa Stain Kit In distribution
Three-Step Solution B In distribution
Rapid-Chrome™ Kwik-Diff™ Staining In distribution
Giemsa Stain In distribution
Kwik-Diff™ Solution 1 In distribution
Wright – Giemsa Stain In distribution
Kwik-Diff™ Solution 2 In distribution
Kwik-Diff™ Stain Kit In distribution
Three-Step Stain Set In distribution
Kwik-Diff™ Solution 3 In distribution
Three-Step Solution A In distribution
Modified Wright-Giemsa Stain Pack In distribution
May-Grunwald Stain In distribution
Wright – Giemsa Stain In distribution
Buffered Wright – Giemsa Stain In distribution
Three-Step Fixative In distribution
Wright – Giemsa Stain In distribution
Jenner Stain In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Alpha-Tec Systems Alpha-Tec Systems, Inc. 5
Chemical Service Labs, LLC Protean Resources, LLC. 2
Fisherbrand Fisher Scientific Company L.L.C. 2
Advia® Autoslide Wright Giemsa Stain Siemens Healthcare Diagnostics Inc 2
Giemsa Staining Kit Ventana Medical Systems, Inc. 1
Atellica Hema SMS W-G Stain Siemens Healthcare Diagnostics Inc 1
Remel Remel, Inc. 1
Hematek® Stain Pak – Wright-Giemsa Stain Siemens Healthcare Diagnostics Inc 1
Atellica Hema SMS W-G Buffer Siemens Healthcare Diagnostics Inc 1
Cardinal Health Cardinal Health 200, LLC 1
Advia Autoslide Giemsa Stain Siemens Healthcare Diagnostics Inc 1
Advia Autoslide May-Grunwald Giemsa Buffer Siemens Healthcare Diagnostics Inc 1

Showing 12 of 13. All products under Giemsa Stain

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated FDA class Root cause Reason Quantity Closed
2017-03-15 Class II Mixed-up of materials/components Methylene Blue, Solution #3 in the Kwik Diff Kit was not Methylene Blue but Crystal Violet instead. 390 2017-07-27

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