CLIA - Clinical Laboratory Improvement Amendments

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New Search Back To Search Results Test System Name BIO-RAD LABORATORIES BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM  {HSV 1 & 2 IgG} (for Serum/Plasma) Document Number K090409 Analyte Name Herpes Simplex Analyte Specialty Virology Complexity MODERATE Effective Date 05/29/2009 Device Classification Name enzyme linked immunosorbent assay, herpes simplex virus, hsv-1 510(k) Number K090409 Device Name BIOPLEX 2200 HSV-1 AND HSV-2 IGG ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM Applicant BIO-RAD LABORATORIES 6565 185th ave, ne redmond,  WA  98052 Contact david v bhend Regulation Number 866.3305 Classification Product Code MXJ   Subsequent Product Code MYF   Date Received 02/18/2009 Decision Date 05/08/2009 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