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U.S. Department of Health and Human Services

Product Classification
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Device over-the-counter covid-19 antigen test
Definition For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.
Physical State Solid phase test device/dip-stick
Technical Method Lateral flow Immunochromatographic Assay
Target Area Anterior Nasal Swabs
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQYT
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
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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