DEVICE: Epredia (00673693089388)
Device Identifier (DI) Information
Epredia
Alcoholic Hematoxylin Solution
In Commercial Distribution
88007
RICHARD-ALLAN SCIENTIFIC COMPANY
Alcoholic Hematoxylin Solution
In Commercial Distribution
88007
RICHARD-ALLAN SCIENTIFIC COMPANY
"Elastic Stain Kit and its components are used as a special stain kit to identify elastic
fibers. The elastic fibers stain black due to the dye lake created by the hematoxylin, ferric chloride and iodine mixture. The fibers are overstained and then differentiated with ferric chloride to break the dye-lake complex. To ensure fibers are not over-differentiated,
slides should be examined during this step under the microscope. Elastic fibers will be
stained black and sharply defined. The Van Gieson solution then counterstains the
tissue with collagen staining red and other tissue structures, yellow. The Van Gieson
solution will also remove some of the elastic fiber staining so the knowledge of a
professional is required for adequate use. After staining, care should be taken in
choosing a compatible mounting medium as some mountants can leach the picric acid
from the Van Gieson counterstain."
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
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? |
---|---|---|---|---|
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LEE | Stains, Dye Solution |
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
b5514bc4-dc4b-469e-94fa-53cb25d969dd
September 04, 2024
1
August 27, 2024
September 04, 2024
1
August 27, 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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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined