Product code PII

Device name
Candida Species Nucleic Acid Detection System
Medical specialty
Microbiology
Device class
2
Regulation number
866.3960
Review panel
MI
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.
Source
FDA openFDA device classification dataset