510(k) DEN200031

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

March 17, 2021

Date Received

May 19, 2020

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

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

Device Class

Class II

Regulation Number

866.3981

Review Panel

MI

Submission Type

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.