{"product_id":"beckman-coulter-reagent-kit-access-r-antibody-test-sars-cov-2-igg-ii-for-use-with-access-family-of-immunoassay-systems-2-x-100-tests-20-aul-sample-volume-kt-1-c69057-kt","title":"Beckman Coulter Reagent Kit Access® Antibody Test SARS-CoV-2 IgG II For use with Access Family of Immunoassay Systems 2 X 100 Tests 20 µL Sample Volume - KT\/1 - C69057-KT","description":"\u003ch3\u003eBeckman Coulter Reagent Kit Access® Antibody Test SARS-CoV-2 IgG II For use with Access Family of...\u003c\/h3\u003e\u003ctable class=\"tblSimple\" summary=\"Product Attributes\"\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eItem Id\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e1183726\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eMF Id#\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eC69057\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eBrand\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eAccess®\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eManufacturer\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eBeckman Coulter\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eCountry of Origin\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eUnited States\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Application \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Reagent Kit \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Container Type \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Well \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e For Use With \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e For use with Access Family of Immunoassay Systems \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Number of Tests \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e 2 X 100 Tests \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Sample Type \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Serum \/ Plasma Sample \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Test Method \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Two-step Enzyme Immunoassay \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Test Name \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e SARS-CoV-2 IgG II \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Test Type \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Antibody Test \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Time to Results \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e 32 Minute Results \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e UNSPSC Code \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e 41116010 \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Volume \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e 20  µL Sample Volume \u003c\/td\u003e \u003c\/tr\u003e \u003c\/table\u003e \u003ch4 id=\"prodfeats\"\u003eFeatures\u003c\/h4\u003e\u003cul id=\"itemFeatures\" class=\"unordered-list\"\u003e \u003cli\u003eThis test has not been reviewed by the FDA\u003c\/li\u003e\n\u003cli\u003eTesting is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.  §263a, that meet requirements to perform high complexity tests\u003c\/li\u003e\n\u003cli\u003eFor U.S.A. only, Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to by or on the order of a physician\u003c\/li\u003e\n\u003cli\u003eThe concentration of SARS-CoV-2 IgG in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods and reagent specificity; values obtained with different assay methods should not be used interchangeably\u003c\/li\u003e\n\u003cli\u003eThe Access SARS-CoV-2 IgG II assay is a paramagnetic particle, chemiluminescent immunoassay intended for the semi-quantitative and qualitative determination of IgG antibodies to SARS-CoV-2 in human serum, serum separator tubes, and plasma (EDTA, citrate and heparin)\u003c\/li\u003e\n\u003cli\u003eAt this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity; Access SARS-CoV-2 IgG II assay should not be used to diagnose or exclude acute SARS-CoV-2 infection\u003c\/li\u003e\n\u003cli\u003eLaboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities\u003c\/li\u003e\n\u003cli\u003eNegative results do not preclude acute SARS-CoV-2 infection\u003c\/li\u003e\n\u003cli\u003ePositive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E\u003c\/li\u003e\n\u003cli\u003e200 determinations, 2 packs, 100 tests\/pack\u003c\/li\u003e\n\u003cli\u003eThe positive percent agreement (PPA) of the Access SARS-CoV-2 IgG II assay is 96.0% at 8-14 days post symptom onset\u003c\/li\u003e\n\u003cli\u003eThe negative percent agreement (NPA) of the Access SARSCoV-2 IgG assay is 99.9% evaluated in a study with 1,448 samples\u003c\/li\u003e\n\u003cli\u003eTime-to-first result (approx.) 32 Minutes\u003c\/li\u003e \u003c\/ul\u003e","brand":"Beckman Coulter","offers":[{"title":"Default Title","offer_id":50904797085996,"sku":"C69057-KT","price":2799.99,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.healthcareorigin.com\/products\/beckman-coulter-reagent-kit-access-r-antibody-test-sars-cov-2-igg-ii-for-use-with-access-family-of-immunoassay-systems-2-x-100-tests-20-aul-sample-volume-kt-1-c69057-kt","provider":"Healthcare Origin","version":"1.0","type":"link"}