Identity
- Trade Name
- HardyDisk™ FDA UDI
- Generic Name
- Antifungal susceptibility testing disc IVD FDA UDI
- Device Name
- Rezafungin 5ug (RZF5),1 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. FDA UDI
- Model / Reference
- Z9471 FDA UDI
- Description
- Rezafungin 5ug (RZF5),1 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. FDA UDI
Identifiers
- Catalog Number
- Z9471 FDA UDI
- Primary DI / UDI-DI
- 00819398021197 FDA UDI
- 510(k) Number
- K230827 FDA UDI
- FDA Product Code
- JTN FDA UDI
- GMDN Term
- Antifungal susceptibility testing disc IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Antifungal susceptibility testing disc IVD
HardyDisk™ by Hardy Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Antifungal susceptibility testing disc IVD.
- HardyDisk™ — HARDY DIAGNOSTICS · Class II
Cleared under the same submission
K230827 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hardy Diagnostics
Sources (1)
- FDA UDI ecc63eca-a0d3-41e8-b1b7-435faf844f9a 37 fields · synced Jun 6, 2026