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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 system for detection of nucleic acid from non-viral microorganism(s) causing stis using specimens collected at home
De Novo Number DEN200070
Device Name Simple 2 Test
Requester
LetsGetChecked Inc. (formerly PrivaPath Diagnostics Inc.)
unit 3, adelphi house, george's st upper
dun laoghaire,  IE a96 ny82
Contact karen walsh
Regulation Number866.3385
Classification Product Code
QYA  
Date Received11/16/2020
Decision Date 11/15/2023
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
Type Direct
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