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U.S. Department of Health and Human Services

Product Classification

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Device respiratory specimen nucleic acid sars-cov-2 test
Definition A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infections by their healthcare providers. The device is intended to aid in the diagnosis of COVID-19 in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.
Physical State A test system that contains all necessary reagents for sample preparation, nucleic acid reverse transcription and amplification, and detection from SARS-CoV-2 nucleic acids from a single respiratory tract specimen.
Technical Method A nucleic acid amplification test (NAAT).
Target Area Human respiratory tract specimens, such as anterior nasal swabs, nasopharyngeal swabs, nasal or nasopharyngeal washes and aspirates, etc.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQQX
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3981
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
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