NGZ

Susceptibility Test Plate, Antifungal

Product code: NGZ
Device name: Susceptibility Test Plate, Antifungal
Device class: Class 2
21 CFR: 21 CFR 866.1640
Medical specialty: Microbiology
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 3
Summaries archived here: 2 (direct download)
510(k) clearances (all years, FDA): 21 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2025-02-27.

Number	Decision date	Applicant	Device name	Summary
K243738	2025-02-27	Thermo Fisher Scientific	The Sensititre YeastOne Susceptibility System with M	—
K232967	2024-06-12	bioMerieux, Inc.	VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg	PDF
K232963	2024-06-07	bioMerieux, Inc.	VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/	PDF

2 summaries are archived here for direct download.

Official FDA classification page: NGZ

Classification and pathway per current FDA publications. Data from openFDA (CC0).