N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00819398027380
• Version / Model: Z78
• Catalog Number: Z78
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-16
• Public Version: 1
• Public Version Date: 2020-06-24
• Public Version Status: New
• Public Device Record Key: fd414903-6f8c-4d2b-a7b2-36c9e1f86ad8

Device Description

Potassium Hydroxide, 20% 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

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JTO	Discs, Strips And Reagents, Microorganism Differentiation	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00819398027380	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius