Product Classification

• Device: mers-cov and common respiratory pathogens semi-quantitative and quantitative multiplex nucleic acid detection system
• Definition: 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.
• Physical State: Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens semi-quantitative or quantitative multiplex nucleic acid detection systems are in vitro diagnostic devices that consist of reagents and associated instrumentation for detection, identification, and quantification of MERS-CoV and common respiratory pathogens – associated nucleic acids in human clinical specimens.
• Technical Method: A qualitative, semi-quantitative or quantitative in vitro diagnostic assay that detects and identifies MERS-CoV and common respiratory pathogens – associated nucleic acids in human clinical specimens.
• Target Area: Human clinical samples
• Regulation Medical Specialty: Pathology
• Review Panel: Microbiology
• Product Code: QDS
• Premarket Review: Office of In Vitro Diagnostics (OHT7); Division of Microbiology Devices (DMD)
• Submission Type: 510(k)
• Regulation Number: 866.4001
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible