medical device H.pylori rapid test kits

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INTENDED USE H.pylorl Antigen Rapid Test Device (feces) is a rapid visual immunoassay for the qualitative presumptive detection of helicobacter pylori antigens in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of H. Pylori infection. PERFORMANCE CHARATERISTICS Specificity: Cross reactivity with following organisms has been studied at 1.0×109 Organisms/ml. The following organisms were found negative when tested with the H. pylori Antigen Rapid Test (Feces). Staphylococcus aureus Proteus mirabilis Neisseria gonorrhea Pseudomonas aeruginosa Acinetobacter spp Group B Streptococcus Enterococcus faecalis Salmonella choleraesius Proteus vulgaris Group C Streptococcus Gardnerella vaginalis Enterococcus faecium Klebsiella pneumoniae Acinetobacter calcoaceticus Hemophilus influenzae Branhamella catarrhalis E.coli Neisseria meningitidis Candida albicans Chlamydia trachomatis Rotavirus

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AccuBioTech Co.,Ltd

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