FDA Product Code QDS: Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System
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.
Leading manufacturers include Biofire Diagnostics, LLC.
List of Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System devices (product code QDS). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →