Epredia

In 1949, Dr. George Brecher developed a stain called new methylene blue to identify immature erythrocytes (reticulocytes) based upon aggregations of RNA within disintegrating ribosomes.…

Registry build 21.09.26

In 1949, Dr. George Brecher developed a stain called new methylene blue to identify immature erythrocytes (reticulocytes) based upon aggregations of RNA within disintegrating ribosomes. This RNA is at its highest level immediately after enucleation of the cell and continues to decrease until its complete absence in the fully mature erythrocyte. Reticulocytes are so named due to their mesh-like (reticular) network of ribosomal RNA which, after staining, is readily visible with a blue granulofilamentous appearance. The quantitative evaluation of reticulocytes in peripheral blood is an important test used in the assessment of erythropoiesis, bone marrow function, and anemia typing.

1manufacturer
1catalogue number

Who Else Makes It

Registered in Shandong.

Chinese manufacturers registered for FDA product code GJH
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 GJH
Device type Stain, Reticulocyte
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
Label carries lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for Epredia
Catalogue number Size Status
Reticulocyte Stain In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Alinity Abbott Laboratories 2
Cell-DYN Abbott Laboratories 2
UF-Fluorocell SF Sysmex Corporation 1
UF-Fluorocell CR Sysmex Corporation 1

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