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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 Number
866.3385
Classification Product Code
QYA
Date Received
11/16/2020
Decision Date
11/15/2023
Decision
granted (DENG)
Classification Advisory Committee
Microbiology
Review Advisory Committee
Microbiology
Classification Order
Classification Order
FDA Review
Decision Summary
Type
Direct
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