Alere Scarborough Inc. / MID 20993 Alere Scarborough Inc. / K1036 10 Trade / Clinical Affairs 10 Southgate Road Scarborough / Escherichia co / Binax Inc. / Clinical Affairs Alere Scarborough Inc. / /
Country
Malaysia / Russia / United States / /
Event
FDA Phase / /
IndustryTerm
Internet address http /
MedicalCondition
ANALYTICAL REACTIVITY TESTING The influenza A / Lactobacil/us casel Parainfluenza / seasonal influenza A / II Influenza A / B viral infections / live influenza A / Haemophilus inf/uenzae Measles / Flu A/Brisbane / influenza virus infection / Flu A/Denver / influenza virus / influenza / predominant influenza A / Lactobacfl/us plantarum Parainfluenza / Kiebsie/la pneumoniae Mumps / novel influenza A / live influenza B / pneumophila Parainfluenza / detect'human infection / influenza A / specific influenza strains causing infection / HINi influenza virus / sub flava Proteus vulgaris Pseudomonas / Flu A/Solomon / Herpes V / influenza B / Clearviewe Exact 1I Influenza A / /
Organization
Division of Postmarket Surveillance / Microbiology Devices Office / Food and Drug Administration / American Society for Microbiology / office of Device / In Vitro Diagnostic Device Evaluation and Safety Center for Devices / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / CDRH's office of Surveillance / /
510(k) SUMMARY JAN[removed]