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U.S. Department of Health and Human Services

Product Classification
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Device ngs whole genome sequencing for sars-cov-2 genetic analysis
Definition This is an IVD test which utilizes a next generation sequencing (NGS) method performed on a high throughput sequencing platform. This test can identify and differentiate SARS-CoV-2 and support additional genetic analysis, when clinically indicated, from SARS-CoV-2-positive samples identified as positive using an EUA authorized diagnostic test. Testing is limited to designated laboratories.
Physical State IVD test
Technical Method Whole genome sequencing using a next generation sequencing (NGS) methodology
Target Area Respiratory specimens
Review Panel Microbiology
Product CodeQTA
Premarket Review Division of Microbiology Devices (DMD)
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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