510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PIIClass II

Candida Species Nucleic Acid Detection System

21 CFR 866.3960 / Microbiology
FDA source (opens on fda.gov)

PII is the FDA product code for Candida Species Nucleic Acid Detection System, a class II device type, regulated under 21 CFR 866.3960. FDA's definition for this code reads: "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...". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
PII
Device name
Candida Species Nucleic Acid Detection System
FDA 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.
Regulation
21 CFR 866.3960
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
1

Clearances, product code PII

By decision year
3 clearances under product code PII with a decision year between 2014 and 2024, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PII by decision year
YearClearances
20141
20171
20241

Applicants with the most clearances

Product code PII
Applicants holding the most 510(k) clearances under product code PII
ApplicantClearances
T2biosystems, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code