DEVICE: Epredia (00673693090063)

Device Identifier (DI) Information

Epredia
Decolorizing Solution
In Commercial Distribution
88104
RICHARD-ALLAN SCIENTIFIC COMPANY
00673693090063
GS1

1
929504710 *Terms of Use
"Gram Stain Kits – Tissue & Film Bacteria can be classified into one of two families based upon structural and compositional differences in their cell walls. Gram-positive bacteria have thick cell walls with high peptidoglycan content, whereas Gram-negative bacteria have thin cell walls with low peptidoglycan content. Both Gram-positive and Gram-negative bacteria stain with the dye- lake formed by Crystal Violet Solution and Gram’s Iodine Solution. However, during rinsing with Decolorizing Solution, this dye-lake is completely removed from the thin-walled Gram- negative bacteria, allowing them to be subsequently stained with Safranin O Stain Solution. The short duration of the decolorization step enables Gram-positive bacteria to retain the crystal violet dye-lake. Care should be taken when rinsing slides with Decolorizing Solution, as extended rinses can cause the crystal violet dye-lake to be removed from Gram-positive bacteria in addition to Gram-negative bacteria. Within the Tissue Kit only, tissue elements are then counterstained yellow by Tartrazine Stain Solution."
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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

[?]
Product Code Product Code Name
LED Stains, Chemical 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

[?]
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

954e536d-38e4-4fe5-92d7-42cb23ca184d
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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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