DEVICE: Epredia (00673693089210)

Device Identifier (DI) Information

Epredia
Methyl Green-Pyronin Y Stain Solution
In Commercial Distribution
87011
RICHARD-ALLAN SCIENTIFIC COMPANY
00673693089210
GS1

1
929504710 *Terms of Use
"Methyl Green-Pyronin-Y Stain Solution is intended for used in differentiating DNA and RNA in tissue sections for the diagnosis of general pathology specimens. The reaction is based upon the competition between the slow staining, but doubly charged, methyl green and the more rapidly staining, singly charged pyronin Y. Methyl green has two cationic charged groups that become linked to the phosphate moieties in the DNA. The pyronin Y displaces the methyl green from all sites of linkage except where its double charge gives it a selective advantage (acidic polymer such as DNA). Consequently, the methyl green stains DNA and retains its binding to this substance against the competitive action of pyronin Y. Pyronin Y stains the less polymerized RNA rapidly and displaces methyl green from linkages having smaller polymeric acidic substances (RNA). The reaction is done at pH 4.2 – pH 4.3. The advantage of a low pH is to have the nucleic acids in a charged condition and in their least soluble state."
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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
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FDA Product Code

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Product Code Product Code Name
HZA Methyl Green
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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

a2b3ac58-2e90-401b-a689-e61196d79f91
September 13, 2024
1
September 05, 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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