DEVICE: Epredia (00673693169004)

Device Identifier (DI) Information

Epredia
Elastic Stain Kit
In Commercial Distribution
87017
RICHARD-ALLAN SCIENTIFIC COMPANY
00673693169004
GS1

1
929504710 *Terms of Use
"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."
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
Yes
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
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FDA Product Code

[?]
Product Code Product Code Name
LEE Stains, Dye Solution
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

0417fb7e-5d01-45e3-94db-64bd2fe2c6ca
September 04, 2024
1
August 27, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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