CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Diagnostic Hybrids D3 DFA Metapneumovirus Identification Kit   Document Number K090073 Analyte Name Human Metapneumovirus (HMPV) Analyte Specialty Virology Complexity HIGH Effective Date 03/12/2009 Device Classification Name antisera, fluorescent, human metapneumovirus 510(k) Number K090073 Device Name D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT Applicant DIAGNOSTIC HYBRIDS, INC. 1055 east state street suite 100 athens,  OH  45701 Contact gail r goodrum Regulation Number 866.3980 Classification Product Code OMG   Date Received 01/12/2009 Decision Date 03/06/2009 Decision substantially equivalent - CLIA submission (CS) Classification Advisory Committee Microbiology Review Advisory Committee Microbiology Statement/Summary/Purged Status Summary only summary summary FDA Review Decision Summary Type Traditional Reviewed by Third Party No Expedited Review No