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Candida Species Nucleic Acid Detection System

FDA product code PII · Class 2 · Microbiology

7
Registered devices
1
Adverse events
1
Recalls
3
510(k) clearances

Devices with this code

T2Dx® QCheck Negative Kit — T2 BIOSYSTEMS, INC.T2Candida® QCheck Positive Kit — T2 BIOSYSTEMS, INC.T2Candida® 1.1 Cartridge Kit — T2 BIOSYSTEMS, INC.T2Candida® Reagent Trays — T2 BIOSYSTEMS, INC.T2Candida® Cartridge Kit — T2 BIOSYSTEMS, INC.T2Dx® QCheck Negative Kit — T2 BIOSYSTEMS, INC.T2Candida® External Controls — T2 BIOSYSTEMS, INC.

Recent recalls

DateFirmReason
2016-07-07T2 Biosystems IncElevated levels of invalid results.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.