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1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Mers-Cov And Common Respiratory Pathogens Multiplex Nucleic Acid Detection System

Device class

Class II (moderate risk)

Regulation

21 CFR 866.4001

Medical specialty

Pathology

FDA definition

A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens multiplex nucleic acid detection system is a qualitative in vitro diagnostic test for the detection and identification of MERS-CoV and common respiratory pathogens – associated nucleic acids in human clinical specimens. The test is indicated for individuals meeting specific MERS-CoV clinical and/or epidemiological criteria. It aids in the differential diagnosis of MERS-CoV infection in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the appropriate public health authorities.

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