NGZ

Product Code: NGZ


Products Classified as NGZ

3506Susceptibility Test Plate, AntifungalAntimicrobial Susceptibility Test Powder.

Total Product Life Cycle (TPLC) Devices

3506Susceptibility Test Plate, AntifungalAntimicrobial Susceptibility Test Powder.

FDA Consensus Standards

Susceptibility Test Plate, Antifungal [38130]21 CFR §866.1640 ๐Ÿ”Ž
Susceptibility Test Plate, Antifungal [31043]21 CFR §866.1640 ๐Ÿ”Ž
Susceptibility Test Plate, Antifungal [37755]21 CFR §866.1640 ๐Ÿ”Ž
Susceptibility Test Plate, Antifungal [33903]21 CFR §866.1640 ๐Ÿ”Ž
Susceptibility Test Plate, Antifungal [37756]21 CFR §866.1640 ๐Ÿ”Ž
Susceptibility Test Plate, Antifungal [37689]21 CFR §866.1640 ๐Ÿ”Ž

Pre-market Notifications for NGZ

K211539Sensititre YeastOne Susceptibility System With Voriconazole In The Dilution Range Of 0.008 - 8 Ug/mLThermo Fisher Scientific
K181368VITEK 2 AST-YS Micafungin (8 ยตg/mL)BioMerieux, Inc.
K151923VITEK 2 AST-Yeast Micafungin (0.06-8 Mcg/mL)BIOMERIEUX, INC.
K151817VITEK 2 AST-YS Caspofungin =8 Ug/mLBIOMERIEUX INC
K133952VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINEBIOMERIEUX, INC.
K133817VITEK 2 AST - YEAST FLUCONAZOLEBIOMERIEUX, INC.
K133038SENSITITRE YEASTONE SUSCEPTIBILITY PLATESTREK DIAGNOSTIC SYSTEMS
K101566VITEK 2 YEAST CASPOFUNGINBIOMERIEUX, INC.
K092454VITEK 2 YEAST VORICONAZOLEBIOMERIEUX, INC.
K090968SENSITITRE YEASTONE SUSCEPTIBILITY PLATESTREK DIAGNOSTIC SYSTEMS, INC.
K082534ETEST VORICONAZOLE 0.002-32 UG/MLAB BIOMERIEUX
K081063SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICSTREK DIAGNOSTIC SYSTEMS, INC.
K061945VITEK 2 AST-YS FLUCONAZOLEBIOMERIEUX, INC.
K040560ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTINGAB BIODISK
K991810MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TESTTREK DIAGNOSTIC SYSTEMS, INC.

Global Unique Device Identification Database

00848838018817Susceptibility Test Plate, Antifungal
03573026619268SUSCEPTIBILITY TEST PLATE, ANTIFUNGAL
03573026378974Susceptibility Test Plate, Antifungal
03573026616014Susceptibility test plate, antifungal
03573026377717Susceptibility Test Plate, Antifungal
03573026252885Susceptibility Test Plate, Antifungal
03573026253318Susceptibility Test Plate, Antifungal
03573026623562Susceptibility test plate, antifungal
03573026373047Susceptibility Test Plate, Antifungal
00848838036835Susceptibility Test Plate, Antifungal

Maude Adverse Events

VITEK? 2 AST-YS08 TEST KITBIOMERIEUX, INC.2018-09-14
VITEK?2 AST-YS08 TEST KITBIOMERIEUX, INC2018-08-10
VITEK? 2 AST-YS08 TEST KITBIOMERIEUX, INC2018-07-11
VITEK? 2 AST-YS08 TEST KITBIOMERIEUX, INC2018-07-10
VITEK 2 REAGENTBIOMERIEUX, INC.2018-06-25
ETEST? ITRACONAZOLEBIOMERIEUX SA2018-06-20
VITEK? 2 AST-YS07 TEST KITBIOMERIEUX, INC.2018-02-07
VITEK? 2 AST-YS07 TEST KITBIOMERIEUX, INC.2018-01-24
VITEK? 2 AST-YS08 TEST KITBIOMERIEUX, INC2018-01-11
VITEK? 2 AST-YS08 TEST KITBIOMERIEUX, INC.2018-01-02
VITEK? 2 AST-YS08 TEST KITBIOMERIEUX, INC.2017-12-22
VITEK? 2 AST-YS08 TEST KITBIOMERIEUX, INC.2017-12-19
VITEK? 2 AST-YS08 TEST KIT.BIOMERIEUX, INC2017-12-18
VITEK? 2 AST-YS08 TEST KITBIOMERIEUX, INC.2017-12-18
VITEK? 2 AST-YS08 TEST KITBIOMERIEUX INC.2017-12-15
VITEK? 2 AST-YS07 TEST KITBIOMERIEUX, INC.2017-12-11
VITEK? 2 AST-YS07 TEST KITBIOMERIEUX, INC2017-12-07
VITEK? 2 AST-YS07 TEST KITBIOMERIEUX, INC.2017-11-30
VITEK? 2 AST-YS08 TEST KITBIOMERIEUX, INC.2017-11-29
VITEK? 2 AST-YS08 TEST KITBIOMERIEUX, INC.2017-11-29
VITEK? 2 AST-YS08 TEST KITBIOMERIEUX, INC2017-11-20
VITEK? 2 AST-YS08 TEST KITBIOMERIEUX, INC.2017-11-15
VITEK CARDBIOMERIEUX2017-05-02
VITEK? 2 AST-YS07 TEST KITBIOMERIEUX, INC2017-02-16
VITEK? 2 AST-YS07 TEST KITBIOMERIEUX, INC2017-02-16
VITEK? 2 AST-YS07 TEST KITBIOMERIEUX, INC2017-01-26
VITEK? 2 AST-YS07 TEST KITBIOMERIEUX, INC2016-10-28
VITEK? 2 AST-YS07 TEST KITBIOMERIEUX, INC2016-09-14
VITEK? 2 AST-YS07 TEST KITBIOMERIEUX, INC2016-09-14
VITEK? 2 AST-YS07 TEST KITBIOMERIEUX, INC2016-09-01
VITEK? 2 AST-YS07BIOMERIEUX, INC2016-07-26
VITEK? 2 AST-YS07 TEST KITBIOM?RIEUX, INC.2016-05-16
VITEK? 2 AST-YS07 TEST KITBIOMERIEUX, INC2016-05-11
VITEK? 2 YEAST ANTIMICROBIAL SUSCEPTIBILITY TEST AST-YS07 TEST KITBIOMERIEUX, INC2016-04-29
ETEST? ITRACONAZOLEBIOMERIEUX, SA2016-03-14
VITEK 2 AST-YS05 TEST KITBIOM?RIEUX, INC.2015-05-19
VITEK 2 AST-YS02 TEST KITBIOMERIEUX, INC.2014-03-06
SENSITITRETREK DIAGNOSTIC SYSTEMS LTD.2011-02-25

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