Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231433 FDA 510(k)
- FDA Product Code
- NGZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.1640 FDA 510(k)
- Regulation Number
- 866.1640 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sensititre YeastOne Susceptibility System with Rezafungin is an antifungal susceptibility test plate used to determine the effectiveness of antifungal medications against yeast infections. This system provides a dilution range of 0.008-8ug/mL for testing susceptibility to rezafungin and other antifungal agents.
The device is manufactured by Thermo Fisher Scientific and is classified as a Class II medical device under product code NGZ. It is supplied as a test plate and is intended for laboratory use in microbiology settings. The device received FDA 510(k) clearance with K number K231433 on August 31, 2023, and is regulated under number 866.1640.
Frequently asked questions
What is the Sensititre YeastOne Susceptibility System with Rezafungin used for?
This system is an antifungal susceptibility test plate used to determine the effectiveness of antifungal medications against yeast infections in laboratory microbiology settings.
How is the Sensititre YeastOne Susceptibility System supplied?
The device is supplied as a test plate and is intended for laboratory use in microbiology settings. It is manufactured by Thermo Fisher Scientific.
What is the dilution range of the Sensititre YeastOne Susceptibility System with Rezafungin?
This system provides a dilution range of 0.008-8ug/mL for testing susceptibility to rezafungin and other antifungal agents.
What is the regulatory status of this device?
The Sensititre YeastOne Susceptibility System with Rezafungin is classified as a Class II medical device under product code NGZ and received FDA 510(k) clearance with K number K231433 on August 31, 2023.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: The Sensititre YeastOne Susceptibility System with Rezafungin in the ..., The Sensititre YeastOne Susceptibility System with Rezafungin in the ..., K231433 FDA 510(k) - The Sensititre YeastOne Susceptibility ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231433 | Class II | Active |
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Manufacturer
- Manufacturer
- Thermo Fisher Scientific
Sources (1)
- FDA 510(k) K231433 24 fields · synced Sep 24, 2026