510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NGZClass II

Susceptibility Test Plate, Antifungal

21 CFR 866.1640 / Microbiology
FDA source (opens on fda.gov)

NGZ is the FDA product code for Susceptibility Test Plate, Antifungal, a class II device type, regulated under 21 CFR 866.1640. FDA's definition for this code reads: "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". As of , FDA records hold 21 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
NGZ
Device name
Susceptibility Test Plate, Antifungal
FDA 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.
Regulation
21 CFR 866.1640
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
21
Ingested recalls
4

Clearances, product code NGZ

By decision year
21 clearances under product code NGZ with a decision year between 2001 and 2025, 2009 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code NGZ by decision year
YearClearances
20011
20041
20061
20093
20102
20143
20162
20181
20211
20233
20242
20251

Applicants with the most clearances

Product code NGZ
Applicants holding the most 510(k) clearances under product code NGZ
ApplicantClearances
bioMerieux, Inc.10
Thermo Fisher Scientific Oy5
Trek Diagnostic Systems, Ltd.4
Ab Biodisk1
Ab Biomerieux1

Companies listing this code with FDA

Companies whose registered establishments list this code