{"product_id":"abbott-reagent-kit-advisedx-antibody-test-sars-cov-2-igg-ii-for-architect-i-system-100-tests-6-6-ml-microparticles-5-9-ml-conjugate-7-9-ml-diluent-kt-1-06s6020-kt","title":"Abbott Reagent Kit AdviseDx Antibody Test SARS-CoV-2 IgG II For ARCHITECT i SysteMCK-100 Tests 6.6 mL Microparticles, 5.9 mL Conjugate, 7.9 mL Diluent - KT\/1 - 06S6020-KT","description":"\u003ch3\u003eAbbott Reagent Kit AdviseDx Antibody Test SARS-CoV-2 IgG II For ARCHITECT i SysteMCK-100 Tests 6.6 ...\u003c\/h3\u003e\u003ctable class=\"tblSimple\" summary=\"Product Attributes\"\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eItem Id\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e1187915\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eMF Id#\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e06S6020\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eBrand\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eAdviseDx\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eManufacturer\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eAbbott\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eCountry of Origin\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eIreland\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 Cartridge \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e For Use With \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e For ARCHITECT i System \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Number of Tests \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e 100 Tests \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Product Dating \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e McKesson Acceptable Dating: we will ship \u0026gt;= 90 days \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Sample Type \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Human Serum \/ Plasma Sample \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Storage Requirements \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Requires Refrigeration \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Test Method \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Chemiluminescent Microparticle Immunoassay (CMIA) \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 UNSPSC Code \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e 41116020 \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Volume \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e 6.6 mL Microparticles, 5.9 mL Conjugate, 7.9 mL Diluent \u003c\/td\u003e \u003c\/tr\u003e \u003c\/table\u003e \u003ch4 id=\"prodfeats\"\u003eFeatures\u003c\/h4\u003e\u003cul id=\"itemFeatures\" class=\"unordered-list\"\u003e \u003cli\u003eThe AdviseDx SARS-CoV-2 IgG II assay is only for use under the Food and Drug Administration’s Emergency Use Authorization: https:\/\/www.fda.gov\/medical-devices\/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\/in-vitro-diagnostics-euas\u003c\/li\u003e\n\u003cli\u003eTesting is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests\u003c\/li\u003e\n\u003cli\u003eLaboratories within the United States and its territories are required to report all results to the appropriate public health authorities\u003c\/li\u003e\n\u003cli\u003eThe AdviseDx SARS-CoV-2 IgG II assay is a chemiluminescent microparticle immunoassay (CMIA) intended for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma on the ARCHITECT i System using serum, serum separator, acid citrate dextrose, sodium citrate, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator, and sodium heparin tubes\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\u003c\/li\u003e\n\u003cli\u003eThe AdviseDx SARS-CoV-2 IgG II assay should not be used to diagnose or exclude acute SARS-CoV-2 infection\u003c\/li\u003e\n\u003cli\u003eNegative results do not preclude acute SARS-CoV-2 infection; if acute infection is suspected, direct testing for SARS-CoV-2 is necessary\u003c\/li\u003e\n\u003cli\u003eFalse positive results for the AdviseDx SARS-CoV-2 IgG II assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes\u003c\/li\u003e\n\u003cli\u003eDue to the risk of false positive results, confirmation of positive results should be considered using a second, different IgG assay\u003c\/li\u003e \u003c\/ul\u003e","brand":"Abbott","offers":[{"title":"Default Title","offer_id":50904794267948,"sku":"06S6020-KT","price":1264.99,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.healthcareorigin.com\/products\/abbott-reagent-kit-advisedx-antibody-test-sars-cov-2-igg-ii-for-architect-i-system-100-tests-6-6-ml-microparticles-5-9-ml-conjugate-7-9-ml-diluent-kt-1-06s6020-kt","provider":"Healthcare Origin","version":"1.0","type":"link"}