HardyDisk™

Basic Information

• Brand Name: HardyDisk™
• Primary DI: 00819398021548
• Version / Model: Z9475
• Catalog Number: Z9475
• Company Name: HARDY DIAGNOSTICS
• Labeler DUNS: 039981550
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2023-09-08
• Public Version: 1
• Public Version Date: 2023-09-18
• Public Version Status: New
• Public Device Record Key: 9c3fb738-1910-4f82-9cec-0c1792db4c2c

Device Description

Rezafungin 5ug (RZF5), 5 x 50 disks, used for semi-quantitative in vitro susceptibility testing by the agar diffusion test procedure(Kirby- Bauer) when there is the need to determine the susceptibility of microorganisms to Rezafungin. Product can be used to determine the zone diameter (mm) of Rezafungin against the following microorganisms for which Rezafungin has been shown to be active both clinically and in vitro: Candida albicans, Candida glabrata, Candida parapsilosis, and Candida tropicalist.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	866.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63835	Antifungal susceptibility testing disc IVD	A susceptibility testing disc impregnated with a defined amount of a specific antifungal, also know as an antimycotic (i.e., a drug intended for treatment and/or prevention of a fungal infection) intended to be used to determine the susceptibility of a specific fungal organism isolated from a clinical specimen by culture, using a disc diffusion method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00819398021180	GS1
Primary	00819398021548	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K230827	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 8 Degrees Celsius