QOF

33 FDA 510(k) clearances · Product code

FDA profile

Official device name

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Device class

Class II (moderate risk)

Regulation

21 CFR 866.3981

Medical specialty

Microbiology

FDA definition

A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.

Adverse events (MAUDE)

2024: 30
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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