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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 biological sterilization indicator with indirect growth detection
De Novo Number DEN220042
Device Name Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
Requester
terragene s.a.
ruta nacional # 9, km 280, parque industrial micropi
alvear,  AR 2130
Contact catalano maximiliano
Regulation Number880.2806
Classification Product Code
QVB  
Date Received07/01/2022
Decision Date 07/12/2024
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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