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U.S. Department of Health and Human Services

Product Classification

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Device over-the-counter molecular test to detect sars-cov-2 from clinical specimens
Definition An over-the-counter molecular test to detect SARS-CoV-2 is an in vitro diagnostic device for the detection of SARS-CoV-2 in clinical specimens to aid in the diagnosis of SARS-CoV-2 infection. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments.
Physical State In vitro diagnostic assay reagents and hardware. The device may include chemical components for the amplification of nucleic acid targets. The device may include hardware and software to allow for data collection and review.
Technical Method Uses nucleic acid amplification technology (NAAT) for the detection of SARS-CoV-2 from clinical samples.
Target Area upper respiratory clinical specimens
Regulation Medical Specialty Clinical Chemistry
Review Panel Microbiology
Product CodeQWB
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3984
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible