PII
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Candida Species Nucleic Acid Detection System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3960
- Medical specialty
- Microbiology
- FDA definition
- The Candida species nucleic acid detection system is a qualitative panel for the direct detection of Candida species in whole blood specimens from patients with symptoms of, or medical conditions predisposing the patients to, invasive fungal infections. The test is indicated for the presumptive diagnosis of candidemia. The test is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification.
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| Record | Firm | Date |
|---|---|---|
| T2Candida 1.1 Panel (K234063) | T2biosystems, Inc. | 2024-09-13 |
| T2Candida 1.1 Panel (K173536) | T2biosystems, Inc. | 2017-12-12 |
| T2CANDIDA AND T2DX INSTRUMENT (DEN140019) | T2biosystems, Inc. | 2014-09-22 |
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