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…
“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.”
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jinan Babio Biotechnology Co., Ltd. | Jinan | Shandong | Manufacturer | 25 |
Record
| 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
| 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 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
| 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.
| 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.