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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 microbial nucleic acid storage and stabilization device
De Novo Number DEN170029
Device Name PrimeStore MTM
Longhorn Vaccines and Diagnostics LLC
2 bethesda metro center, suite 910
bethesda,  MD  20814
Contact jeff fischer
Regulation Number866.2950
Classification Product Code
Date Received05/24/2017
Decision Date 03/19/2018
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct