NGZ

Product Code: NGZ

Products Classified as NGZ

3506

Susceptibility Test Plate, Antifungal

Antimicrobial Susceptibility Test Powder.

Total Product Life Cycle (TPLC) Devices

3506

Susceptibility Test Plate, Antifungal

Antimicrobial Susceptibility Test Powder.

FDA Consensus Standards

• Susceptibility Test Plate, Antifungal [38130]: 21 CFR §866.1640 🔎
• Susceptibility Test Plate, Antifungal [31043]: 21 CFR §866.1640 🔎
• Susceptibility Test Plate, Antifungal [37755]: 21 CFR §866.1640 🔎
• Susceptibility Test Plate, Antifungal [33903]: 21 CFR §866.1640 🔎
• Susceptibility Test Plate, Antifungal [37756]: 21 CFR §866.1640 🔎
• Susceptibility Test Plate, Antifungal [37689]: 21 CFR §866.1640 🔎

Pre-market Notifications for NGZ

K211539	Sensititre YeastOne Susceptibility System With Voriconazole In The Dilution Range Of 0.008 - 8 Ug/mL	Thermo Fisher Scientific
K181368	VITEK 2 AST-YS Micafungin (8 µg/mL)	BioMerieux, Inc.
K151923	VITEK 2 AST-Yeast Micafungin (0.06-8 Mcg/mL)	BIOMERIEUX, INC.
K151817	VITEK 2 AST-YS Caspofungin =8 Ug/mL	BIOMERIEUX INC
K133952	VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE	BIOMERIEUX, INC.
K133817	VITEK 2 AST - YEAST FLUCONAZOLE	BIOMERIEUX, INC.
K133038	SENSITITRE YEASTONE SUSCEPTIBILITY PLATES	TREK DIAGNOSTIC SYSTEMS
K101566	VITEK 2 YEAST CASPOFUNGIN	BIOMERIEUX, INC.
K092454	VITEK 2 YEAST VORICONAZOLE	BIOMERIEUX, INC.
K090968	SENSITITRE YEASTONE SUSCEPTIBILITY PLATES	TREK DIAGNOSTIC SYSTEMS, INC.
K082534	ETEST VORICONAZOLE 0.002-32 UG/ML	AB BIOMERIEUX
K081063	SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS	TREK DIAGNOSTIC SYSTEMS, INC.
K061945	VITEK 2 AST-YS FLUCONAZOLE	BIOMERIEUX, INC.
K040560	ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING	AB BIODISK
K991810	MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST	TREK DIAGNOSTIC SYSTEMS, INC.

Global Unique Device Identification Database

• 00848838018817: Susceptibility Test Plate, Antifungal
• 03573026619268: SUSCEPTIBILITY TEST PLATE, ANTIFUNGAL
• 03573026378974: Susceptibility Test Plate, Antifungal
• 03573026616014: Susceptibility test plate, antifungal
• 03573026377717: Susceptibility Test Plate, Antifungal
• 03573026252885: Susceptibility Test Plate, Antifungal
• 03573026253318: Susceptibility Test Plate, Antifungal
• 03573026623562: Susceptibility test plate, antifungal
• 03573026373047: Susceptibility Test Plate, Antifungal
• 00848838036835: Susceptibility Test Plate, Antifungal
• 03573026377731: Susceptibility Test Plate, Antifungal
• M578YO3IVD2: Susceptibility Test Plate, Antifungal
• M578YO2IVD2: Susceptibility Test Plate, Antifungal
• 05032384511419: Susceptibility Test Plate, Antifungal
• 05032384571321: Susceptibility Test Plate, Antifungal

Maude Adverse Events

VITEK? 2 AST-YS08 TEST KIT	BIOMERIEUX, INC.	2018-09-14
VITEK?2 AST-YS08 TEST KIT	BIOMERIEUX, INC	2018-08-10
VITEK? 2 AST-YS08 TEST KIT	BIOMERIEUX, INC	2018-07-11
VITEK? 2 AST-YS08 TEST KIT	BIOMERIEUX, INC	2018-07-10
VITEK 2 REAGENT	BIOMERIEUX, INC.	2018-06-25
ETEST? ITRACONAZOLE	BIOMERIEUX SA	2018-06-20
VITEK? 2 AST-YS07 TEST KIT	BIOMERIEUX, INC.	2018-02-07
VITEK? 2 AST-YS07 TEST KIT	BIOMERIEUX, INC.	2018-01-24
VITEK? 2 AST-YS08 TEST KIT	BIOMERIEUX, INC	2018-01-11
VITEK? 2 AST-YS08 TEST KIT	BIOMERIEUX, INC.	2018-01-02
VITEK? 2 AST-YS08 TEST KIT	BIOMERIEUX, INC.	2017-12-22
VITEK? 2 AST-YS08 TEST KIT	BIOMERIEUX, INC.	2017-12-19
VITEK? 2 AST-YS08 TEST KIT.	BIOMERIEUX, INC	2017-12-18
VITEK? 2 AST-YS08 TEST KIT	BIOMERIEUX, INC.	2017-12-18
VITEK? 2 AST-YS08 TEST KIT	BIOMERIEUX INC.	2017-12-15
VITEK? 2 AST-YS07 TEST KIT	BIOMERIEUX, INC.	2017-12-11
VITEK? 2 AST-YS07 TEST KIT	BIOMERIEUX, INC	2017-12-07
VITEK? 2 AST-YS07 TEST KIT	BIOMERIEUX, INC.	2017-11-30
VITEK? 2 AST-YS08 TEST KIT	BIOMERIEUX, INC.	2017-11-29
VITEK? 2 AST-YS08 TEST KIT	BIOMERIEUX, INC.	2017-11-29
VITEK? 2 AST-YS08 TEST KIT	BIOMERIEUX, INC	2017-11-20
VITEK? 2 AST-YS08 TEST KIT	BIOMERIEUX, INC.	2017-11-15
VITEK CARD	BIOMERIEUX	2017-05-02
VITEK? 2 AST-YS07 TEST KIT	BIOMERIEUX, INC	2017-02-16
VITEK? 2 AST-YS07 TEST KIT	BIOMERIEUX, INC	2017-02-16
VITEK? 2 AST-YS07 TEST KIT	BIOMERIEUX, INC	2017-01-26
VITEK? 2 AST-YS07 TEST KIT	BIOMERIEUX, INC	2016-10-28
VITEK? 2 AST-YS07 TEST KIT	BIOMERIEUX, INC	2016-09-14
VITEK? 2 AST-YS07 TEST KIT	BIOMERIEUX, INC	2016-09-14
VITEK? 2 AST-YS07 TEST KIT	BIOMERIEUX, INC	2016-09-01
VITEK? 2 AST-YS07	BIOMERIEUX, INC	2016-07-26
VITEK? 2 AST-YS07 TEST KIT	BIOM?RIEUX, INC.	2016-05-16
VITEK? 2 AST-YS07 TEST KIT	BIOMERIEUX, INC	2016-05-11
VITEK? 2 YEAST ANTIMICROBIAL SUSCEPTIBILITY TEST AST-YS07 TEST KIT	BIOMERIEUX, INC	2016-04-29
ETEST? ITRACONAZOLE	BIOMERIEUX, SA	2016-03-14
VITEK 2 AST-YS05 TEST KIT	BIOM?RIEUX, INC.	2015-05-19
VITEK 2 AST-YS02 TEST KIT	BIOMERIEUX, INC.	2014-03-06
SENSITITRE	TREK DIAGNOSTIC SYSTEMS LTD.	2011-02-25