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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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.
Product CodeQTA
Device Class Not Classified

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