NGZ — Susceptibility Test Plate, Antifungal Class II
Classification Details
- Product Code
- NGZ
- Device Class
- Class II
- Regulation Number
- 866.1640
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
The device is an in vitro diagnostic device intended for use in determining quantitative susceptibility of Candida species to various antifungal agents diluted in varying concentration in a microtiter plate format.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243738 | thermo fisher scientific | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution ra | February 27, 2025 |
| K232967 | biomerieux | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) | June 12, 2024 |
| K232963 | biomerieux | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) | June 7, 2024 |
| K231433 | thermo fisher scientific | The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution ra | August 31, 2023 |
| K221198 | thermo fisher scientific | Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range | March 10, 2023 |
| K221899 | thermo fisher scientific | The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution r | January 20, 2023 |
| K211539 | thermo fisher scientific | Sensititre YeastOne Susceptibility System with Voriconazole in the dilution rang | December 15, 2021 |
| K181368 | biomerieux | VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) | June 20, 2018 |
| K151923 | biomerieux | VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) | March 25, 2016 |
| K151817 | biomerieux | VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL | February 18, 2016 |
| K133952 | biomerieux | VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE | August 19, 2014 |
| K133817 | biomerieux | VITEK 2 AST - YEAST FLUCONAZOLE | August 5, 2014 |
| K133038 | trek diagnostic systems | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | January 31, 2014 |
| K101566 | biomerieux | VITEK 2 YEAST CASPOFUNGIN | September 28, 2010 |
| K092454 | biomerieux | VITEK 2 YEAST VORICONAZOLE | May 21, 2010 |
| K082534 | ab biomerieux | ETEST VORICONAZOLE 0.002-32 UG/ML | November 2, 2009 |
| K090968 | trek diagnostic systems | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | June 4, 2009 |
| K081063 | trek diagnostic systems | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS | March 6, 2009 |
| K061945 | biomerieux | VITEK 2 AST-YS FLUCONAZOLE | September 19, 2006 |
| K040560 | ab biodisk | ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING | July 27, 2004 |