inforMED
QDSClass II

Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System

Pathology · 21 CFR 866.4001

A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens qualitative, semi-quantitative or quantitative multiplex nucleic acid detection system is an in vitro diagnostic test for the detection, identification, and quantification 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.

MDR events7All time
Recalls5All time
Registered firms3Currently listed
510(k) clearances3All time

Recent MDR events

7 adverse event reports on file

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Event type breakdown

Death3
Injury3
Malfunction1

Most-reported manufacturers

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Biofire Diagnostics, Llc7

Recalls

5 recall events for this product code

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Registered firms

3 firms currently registered for this product code

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510(k) clearances

3 clearances for this product code

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