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Device Classification Name
groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system
De Novo Number
DEN140005
510(K) Number
K133883
Device Name
LYRA DIRECT STREP ASSAY
Requester
quidel corporation
2005 east state st., suite 100
athens, OH 45701
Contact
ronald h lollar
Regulation Number
866.2680
Classification Product Code
PGX
Date Received
03/25/2014
Decision Date
04/16/2014
Decision
granted (DENG)
Classification Advisory Committee
Microbiology
Review Advisory Committee
Microbiology
Classification Order
Classification Order
FDA Review
Decision Summary
Type
Post-NSE
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