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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


Premarket Reviews
ManufacturerDecision
T2 BIOSYSTEMS, INC
  GRANTED 1
T2 BIOSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 T2 Biosystems Inc II Sep-14-2016
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