DEVICE: Epredia (00673693089869)
Device Identifier (DI) Information
Epredia
Gomori’s Trichrome Stain Green Collagen
In Commercial Distribution
88031
RICHARD-ALLAN SCIENTIFIC COMPANY
Gomori’s Trichrome Stain Green Collagen
In Commercial Distribution
88031
RICHARD-ALLAN SCIENTIFIC COMPANY
Gomori’s Trichrome Stain Kit Green Collagen and its components are used as a special stain kit to distinguish between collagen and muscle fibers. The cytoplasmic stain and the collagen stain are combined into one solution along with phosphotungstic-phosphomolybdic and glacial acetic acids. Muscle cells and cytoplasm favor the red dyes, and this is facilitated by the phosphotungstic acid. Collagen fibers take up the tungstate ion, allowing for the green dye to selectively bind.
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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HYW | Stain, Trichrome, Mallory'S |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
196b3b37-25b5-4d3c-ad70-76090bf499c6
September 13, 2024
1
September 05, 2024
September 13, 2024
1
September 05, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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Secondary DI
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No Secondary DIs found |
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