Panels › Microbiology › Product code NGZ · Class 2
Susceptibility Test Plate, Antifungal
Regulation 866.1640
0510(k)s in 12 months (21 all time)
1recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in NGZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Ab Biomerieux | 11 | 3 |
| Thermo Fisher Scientific | 5 | 0 |
| Trek Diagnostic Systems | 4 | 0 |
| Ab Biodisk | 1 | 0 |
| Remel, Inc | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 27, 2025 | K243738 | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL Thermo Fisher Scientific | NGZ |
| Jun 12, 2024 | K232967 | VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) bioMerieux, Inc. | NGZ |
| Jun 7, 2024 | K232963 | VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) bioMerieux, Inc. | NGZ |
| Aug 31, 2023 | K231433 | The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL Thermo Fisher Scientific | NGZ |
| Mar 10, 2023 | K221198 | Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL Thermo Fisher Scientific | NGZ |
| Jan 20, 2023 | K221899 | The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml Thermo Fisher Scientific | NGZ |
| Dec 15, 2021 | K211539 | Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL Thermo Fisher Scientific | NGZ |
| Jun 20, 2018 | K181368 | VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) bioMerieux, Inc. | NGZ |
| Mar 25, 2016 | K151923 | VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) bioMerieux, Inc. | NGZ |
| Feb 18, 2016 | K151817 | VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL bioMerieux, Inc. | NGZ |
| Aug 19, 2014 | K133952 | VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE bioMerieux, Inc. | NGZ |
| Aug 5, 2014 | K133817 | VITEK 2 AST - YEAST FLUCONAZOLE bioMerieux, Inc. | NGZ |
| Jan 31, 2014 | K133038 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES Trek Diagnostic Systems | NGZ |
| Sep 28, 2010 | K101566 | VITEK 2 YEAST CASPOFUNGIN bioMerieux, Inc. | NGZ |
| May 21, 2010 | K092454 | VITEK 2 YEAST VORICONAZOLE bioMerieux, Inc. | NGZ |
| Nov 2, 2009 | K082534 | ETEST VORICONAZOLE 0.002-32 UG/ML Ab Biomerieux, SE | NGZ |
| Jun 4, 2009 | K090968 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc. | NGZ |
| Mar 6, 2009 | K081063 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS Trek Diagnostic Systems, Inc. | NGZ |
| Sep 19, 2006 | K061945 | VITEK 2 AST-YS FLUCONAZOLE bioMerieux, Inc. | NGZ |
| Jul 27, 2004 | K040560 | ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING Ab Biodisk, SE | NGZ |
| Oct 9, 2001 | K991810 | MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST Trek Diagnostic Systems, Inc. | NGZ |
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