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U.S. Department of Health and Human Services

Product Classification
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Device coronavirus marker detection
Definition Coronavirus marker detection
Physical State IVD
Technical Method Volatile Organic Compounds
Target Area Detection of VOC(s) from human breath specimens
Review Panel Microbiology
Product CodeQSH
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Not Classified Reason EUA - Emergency Use Authorization
Submission Type EUA - Emergency Use Authorization
Device Class Not Classified
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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