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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name high throughput sequencing based tumor profiling test of circulating cell-free nucleic acids
De Novo Number DEN230046
Device Name PGDx elio plasma focus Dx
Requester
personal genome diagnostics, inc.
3600 boston street
suite 10
baltimore,  MD  21224
Contact jennifer dickey
Regulation Number866.6085
Classification Product Code
SBY  
Date Received06/30/2023
Decision Date 08/01/2024
Decision granted (DENG)
Classification Advisory Committee Pathology
Review Advisory Committee Pathology
Reclassification Order Reclassification Order
Type Direct
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