CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name Diagnostic Hybrids D3 FastPoint L-DFA Respiratory Virus Identification Kit  {Influenza A, Influenza B, RSV, hMPV, Adenovirus} (HPIV1, HPIV2 and HPIV3) Document Number K091171 Analyte Name Human Metapneumovirus (HMPV) Analyte Specialty Virology Complexity HIGH Effective Date 09/30/2009 Device Classification Name antisera, fluorescent, human metapneumovirus 510(k) Number K091171 Device Name D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT Applicant DIAGNOSTIC HYBRIDS, INC. 1055 east state street suite 100 athens,  OH  45701 Contact ronald h lollar Regulation Number 866.3980 Classification Product Code OMG   Subsequent Product Codes GNS   GNY   GQS   LKT   Date Received 04/22/2009 Decision Date 09/11/2009 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