Product code NGZ— Microbiology
SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
- Classification name
- Susceptibility Test Plate, Antifungal
- Device class
- Class 2
- Regulation
- 21 CFR 866.1640
- Advisory panel
- Microbiology
- Total cleared
- 21
- First cleared
- Most recent
FDA classification 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.”
Market context for product code NGZ
FDA has cleared devices under product code NGZ between 2001 and 2025, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2024
- 2023
- 2021
- 2018
- 2016
- 2014
- 2010
- 2009
- 2006
- 2004
- 2001
Top applicants under product code NGZ
Recent clearances under product code NGZ
- K243738 — The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL
- K232967 — VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)
- K232963 — VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
- K231433 — The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
- K221198 — Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL
- K221899 — The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml
- K211539 — Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL
- K181368 — VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)
- K151923 — VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)
- K151817 — VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL
- K133952 — VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE
- K133817 — VITEK 2 AST - YEAST FLUCONAZOLE
- K133038 — SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
- K101566 — VITEK 2 YEAST CASPOFUNGIN
- K092454 — VITEK 2 YEAST VORICONAZOLE
- K082534 — ETEST VORICONAZOLE 0.002-32 UG/ML
- K090968 — SENSITITRE YEASTONE SUSCEPTIBILITY PLATES
- K081063 — SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS
- K061945 — VITEK 2 AST-YS FLUCONAZOLE
- K040560 — ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING
- K991810 — MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.