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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 simple in vitro diagnostic device for the detection of secreted proteins from bacillus spp. in human clinical samples
De Novo Number DEN220044
Device Name Active Anthrax DetectTM Plus Rapid Test
Requester
inbios international, inc.
307 westlake ave n, suite 300
seattle,  WA  98109
Contact estela raychaudhuri
Regulation Number866.3046
Classification Product Code
QUU  
Date Received07/08/2022
Decision Date 02/03/2023
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
Type Direct
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