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 and Biofire Diagnostics, LLC (Biomerieux).
FDA 510(k) Cleared Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System Devices (Product Code QDS)
About Product Code QDS - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QDS since 2018, with 3 receiving FDA clearance (average review time: 90 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QDS have taken an average of 30 days to reach a decision - down from 120 days historically, suggesting improved FDA processing for this classification.
QDS devices are reviewed by the Microbiology panel. Browse all Microbiology devices →