PZF

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

Product code

PZF

Device name

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

Device class

Class 2

21 CFR

21 CFR 866.4001

Medical specialty

Pathology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).