DEVICE: N/A (00816576025121)

Device Identifier (DI) Information

N/A
Z77
In Commercial Distribution
Z77
HARDY DIAGNOSTICS
00816576025121
GS1

1
039981550 *Terms of Use
Potassium Hydroxide, 10% KOH, for skin fungal preps, 15ml dropper vial For use in slide preparations of specimens for the purpose of identifying fungal elements. Dissolves epithelial cells that may mask fungi.
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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?
33831 Fixative, acid
An agent containing acid employed in the preparation of a histologic or pathologic human specimen for the purpose of maintaining the existing form and structure of all of its constituent elements to be used for general diagnostic applications.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JTO Discs, Strips And Reagents, Microorganism Differentiation
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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
Storage Environment Temperature: between 15 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

c8cda4a9-7947-47ac-a90f-a361f62b8a43
January 16, 2024
1
January 08, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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
No
No CLOSE

Customer Contact

[?]
800-266-2222
techservice@hardydiagnostics.com
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