DEVICE: Epredia (00673693068192)
Device Identifier (DI) Information
Epredia
Buffered Wright - Giemsa Stain
In Commercial Distribution
3121
RICHARD-ALLAN SCIENTIFIC COMPANY
Buffered Wright - Giemsa Stain
In Commercial Distribution
3121
RICHARD-ALLAN SCIENTIFIC COMPANY
"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."
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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43587 | Biological stain IVD |
A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HYF | Giemsa Stain |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
2db0b810-365e-40e0-80bd-85c3b4967a5c
September 13, 2024
1
September 05, 2024
September 13, 2024
1
September 05, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined