Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
QMV · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3966
Classification
FDA Product Code
QMV
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3966
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A device to detect and identify selected microbial agents that cause acute febrile illness is identified as a in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who may have been exposed to these agents. It is intended to aid in the diagnosis of acute febrile illness in conjunction with other clinical, epidemiologic, and laboratory data, including patient travel, pathogen endemicity, or other risk factors.