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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device candida species nucleic acid detection system
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.
Product CodePII
Regulation Number 866.3960
Device Class 2

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