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WebCLIA WAIVED Test for Whole Blood QUALITATIVE IN-VITRO DIAGNOSTIC TEST FOR EXTERNAL USE ONLY 33-9475 REV A 041105 Page 1 of 1 INTENDED USE INSTANT-VIEWÒH. pylori Rapid Testis a rapid qualitative immunoassay intended to detect the presence of IgG antibodies specific to Helicobacter pylori(H. pylori) in human whole blood. WebJan 5, 2015 · All test methods performed in our central laboratory are validated, including CLIA-waived tests. This presented a unique challenge for the POCone, a new 13 C-urea breath test device, because the manufacturer did not provide calibrators or controls. The POCone was to replace the UBiT; both are manufactured by Otsuka Pharmaceutical Co, … things that have vitamin d
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