PIIClass II
Candida Species Nucleic Acid Detection System
Microbiology · 21 CFR 866.3960
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.
MDR events1All time
Recalls1All time
Registered firms3Currently listed
510(k) clearances3All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Malfunction1
Most-reported manufacturers
Registered firms
3 firms currently registered for this product code
510(k) clearances
3 clearances for this product code