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U.S. Department of Health and Human Services

Product Classification

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Device simple point-of-care device to directly detect sars-cov-2 viral targets from clinical specimens in near-patient settings
Definition A simple point-of-care device to detect SARS-CoV-2 viral targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory
Physical State Simple qualitative in vitro diagnostic device
Technical Method Detection of SARS-CoV-2 viral targets directly from human clinical specimens
Target Area Direct human clinical specimens
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQVF
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3982
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