DEVICE: N/A (00816576025121)
Device Identifier (DI) Information
N/A
Z77
In Commercial Distribution
Z77
HARDY DIAGNOSTICS
Z77
In Commercial Distribution
Z77
HARDY DIAGNOSTICS
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.
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JTO | Discs, Strips And Reagents, Microorganism Differentiation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c8cda4a9-7947-47ac-a90f-a361f62b8a43
January 16, 2024
1
January 08, 2024
January 16, 2024
1
January 08, 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 |
---|---|---|---|---|---|
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
[?]
800-266-2222
techservice@hardydiagnostics.com
techservice@hardydiagnostics.com