Product code NGZ
- Device name
- Susceptibility Test Plate, Antifungal
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.1640
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243738 | The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL | Thermo Fisher Scientific | 2025-02-27 |
| K232967 | VITEK 2 AST-Yeast Voriconazole (= 4 µg/mL) | bioMerieux, Inc. | 2024-06-12 |
| K232963 | VITEK 2 AST-Yeast Anidulafungin (= 8 µg/mL) | bioMerieux, Inc. | 2024-06-07 |
| K231433 | The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL | Thermo Fisher Scientific | 2023-08-31 |
| K221198 | Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL | Thermo Fisher Scientific | 2023-03-10 |
| K221899 | The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml | Thermo Fisher Scientific | 2023-01-20 |
| K211539 | Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL | Thermo Fisher Scientific | 2021-12-15 |
| K181368 | VITEK 2 AST-YS Micafungin (8 µg/mL) | bioMerieux, Inc. | 2018-06-20 |
| K151923 | VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) | bioMerieux, Inc. | 2016-03-25 |
| K151817 | VITEK 2 AST-YS Caspofungin =8 ug/mL | bioMerieux, Inc. | 2016-02-18 |
| K133952 | VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE | bioMerieux, Inc. | 2014-08-19 |
| K133817 | VITEK 2 AST - YEAST FLUCONAZOLE | bioMerieux, Inc. | 2014-08-05 |
| K133038 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | Trek Diagnostic Systems | 2014-01-31 |
| K101566 | VITEK 2 YEAST CASPOFUNGIN | bioMerieux, Inc. | 2010-09-28 |
| K092454 | VITEK 2 YEAST VORICONAZOLE | bioMerieux, Inc. | 2010-05-21 |
| K082534 | ETEST VORICONAZOLE 0.002-32 UG/ML | Ab Biomerieux | 2009-11-02 |
| K090968 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | Trek Diagnostic Systems, Inc. | 2009-06-04 |
| K081063 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES- ADDITIONAL ANTIMICROBICS | Trek Diagnostic Systems, Inc. | 2009-03-06 |
| K061945 | VITEK 2 AST-YS FLUCONAZOLE | bioMerieux, Inc. | 2006-09-19 |
| K040560 | ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING | Ab Biodisk | 2004-07-27 |
| K991810 | MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST | Trek Diagnostic Systems, Inc. | 2001-10-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05032384474561 | Sensititre | TREK DIAGNOSTIC SYSTEMS LIMITED | 2024-07-25 |
| 05032384503513 | Sensititre | TREK DIAGNOSTIC SYSTEMS LIMITED | 2024-07-25 |
| 05032384571413 | Sensititre | TREK DIAGNOSTIC SYSTEMS LIMITED | 2024-07-25 |
| 05032384571451 | Sensititre | TREK DIAGNOSTIC SYSTEMS LIMITED | 2024-07-25 |
| 05032384511419 | Sensititre | TREK DIAGNOSTIC SYSTEMS LIMITED | 2024-07-24 |
| 05032384571321 | Sensititre | TREK DIAGNOSTIC SYSTEMS LIMITED | 2024-07-24 |
| 05032384571611 | Sensititre | TREK DIAGNOSTIC SYSTEMS LIMITED | 2024-07-24 |
| 05032384571789 | Sensititre | TREK DIAGNOSTIC SYSTEMS LIMITED | 2024-07-24 |
| 00848838036835 | SENSITITRE YEASTONE SUSCEPTIBILITY PLATES | REMEL, INC. | 2023-06-20 |
| 03573026623562 | ETEST® | BIOMERIEUX SA | 2021-12-03 |
| 03573026623838 | ETEST® Fluconazole (FL) | BIOMERIEUX SA | 2021-12-03 |
| 03573026616014 | Etest® ITRACONAZOLE | BIOMERIEUX SA | 2019-10-22 |
| 03573026550363 | ETEST® Itraconazole (IT) | BIOMERIEUX SA | 2019-10-22 |
| 03573026619268 | VITEK 2 ® AST-YS09 | BIOMERIEUX , INC. | 2019-04-05 |
| 03573026619350 | VITEK® 2 AST-YS09 | BIOMERIEUX , INC. | 2019-04-05 |
| 03573026373047 | VITEK® 2 AST-YS05 | BIOMERIEUX , INC. | 2017-01-09 |
| 03573026529758 | VITEK® 2 AST-YS05 | BIOMERIEUX , INC. | 2017-01-09 |
| 03573026550516 | ETEST® Voriconazole (VO) | BIOMERIEUX SA | 2016-12-12 |
| 03573026550165 | ETEST® Flucytosine (FC) | BIOMERIEUX SA | 2016-12-12 |
| 03573026550158 | ETEST® Fluconazole (FL) | BIOMERIEUX SA | 2016-12-12 |
| 03573026377731 | ETEST® Flucytosine (FC) | BIOMERIEUX SA | 2016-12-12 |
| 03573026377717 | Etest® FLUCONAZOLE | BIOMERIEUX SA | 2016-12-12 |
| 03573026378974 | Etest® VORICONAZOLE | BIOMERIEUX SA | 2016-12-12 |
| 03573026549091 | Etest® ITRACONAZOLE | BIOMERIEUX SA | 2016-11-18 |
| 03573026548896 | ETEST® Flucytosine (FC) | BIOMERIEUX SA | 2016-11-18 |
| 03573026253318 | Etest® ITRACONAZOLE | BIOMERIEUX SA | 2016-11-18 |
| 03573026252885 | Etest® FLUCYTOSINE | BIOMERIEUX SA | 2016-11-18 |
| 03573026548889 | Etest® FLUCONAZOLE | BIOMERIEUX SA | 2016-11-18 |
| M578YO2IVD2 | Sensititre | TREK DIAGNOSTIC SYSTEMS LIMITED | 2016-09-24 |
| M578YO3IVD2 | Sensititre | TREK DIAGNOSTIC SYSTEMS LIMITED | 2016-09-24 |