{"product_id":"immunoassay-control-set-lumiradx™-sars-cov-2-ag-positive-level-negative-level-4-x-0-5-ml-kit-of-1-mk-1285071-copy","title":"Immunoassay Control Set LumiraDx™ SARS-CoV-2 Ag Positive Level \/ Negative Level 4 X 0.5 mL EACH MK-1197712","description":"\u003cdiv id=\"specifications\" class=\"row fixed-navbar-item\"\u003e\n\u003cdiv class=\"col-lg-12 col-md-12\"\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-md-6\"\u003e\n\u003cdiv id=\"specifications\" class=\"row fixed-navbar-item\"\u003e\n\u003cdiv class=\"col-lg-12 col-md-12\"\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-md-6\"\u003e\n\u003cdiv id=\"specifications\" class=\"row fixed-navbar-item\"\u003e\n\u003cdiv class=\"col-lg-12 col-md-12\"\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-md-6\"\u003e\n\u003cdiv id=\"specifications\" class=\"row fixed-navbar-item\"\u003e\n\u003cdiv class=\"col-lg-12 col-md-12\"\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-md-6\"\u003e\n\u003cdiv id=\"specifications\" class=\"row fixed-navbar-item\"\u003e\n\u003cdiv class=\"col-lg-12 col-md-12\"\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-md-6\"\u003e\n\u003cdiv id=\"specifications\" class=\"row fixed-navbar-item\"\u003e\n\u003cdiv class=\"col-lg-12 col-md-12\"\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-md-6\"\u003e\n\u003ch6 id=\"features\"\u003eFeatures\u003c\/h6\u003e\n\u003cul class=\"product-features\"\u003e\n\u003cli\u003eThe LumiraDx SARS-CoV-2 Ag Test is for use under an Emergency Use Authorization ONLY: https:\/\/www.fda.gov\/medical-devices\/emergency-situations-medical-devices\/emergency-use-authorizations\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 the requirements to perform moderate, high or waived complexity tests\u003c\/li\u003e\n\u003cli\u003eThis test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation\u003c\/li\u003e\n\u003cli\u003eThe LumiraDx SARS-CoV-2 Ag test does not differentiate between SARS-CoV and SARS-CoV-2\u003c\/li\u003e\n\u003cli\u003ePositive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status; positive results do not rule out bacterial infection or co-infection with other viruses\u003c\/li\u003e\n\u003cli\u003eNegative results, from patients with symptoms onset beyond twelve days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed\u003c\/li\u003e\n\u003cli\u003eNegative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions\u003c\/li\u003e\n\u003cli\u003eThe LumiraDx SARS-CoV-2 Ag Quality Controls (hereafter referred to as Quality Controls) are liquid quality controls to be used with the LumiraDx Instrument (hereafter referred to as the Instrument) and the LumiraDx SARS-CoV-2 Ag Test (hereafter referred to as SARS-CoV-2 Ag Test)\u003c\/li\u003e\n\u003cli\u003eThe LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip\u003c\/li\u003e\n\u003cli\u003eThe LumiraDx SARS-CoV-2 Ag Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings, and proficient in performing tests using the LumiraDx Instrument\u003c\/li\u003e\n\u003cli\u003eKit contents: 2 X 0.5ml vial SARS-CoV-2 Ag Positive Control, 2 X 0.5ml vial SARS-CoV-2 Ag Negative Control, 24 Transfer pipettes (20µl), LumiraDx SARS-CoV-2 Ag Quality Control Pack Insert\u003c\/li\u003e\n\u003cli\u003eRequires: LumiraDx Instrument, LumiraDx SARS-CoV-2 Ag Test Strips, and LumiraDx Connect– if connectivity required (refer to LumiraDx Connect User Manual)\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 class=\"page-section h3\" tabindex=\"0\"\u003eProduct Specifications\u003c\/h2\u003e\n\u003chr class=\"bb\"\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-md-6\" tabindex=\"0\"\u003e\n\u003cdiv class=\"table-responsive\"\u003e\n\u003ctable class=\"table table-hover blue\" role=\"presentation\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eMcKesson #\u003c\/th\u003e\n\u003ctd\u003e1197712\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eManufacturer #\u003c\/th\u003e\n\u003ctd\u003eL016080109002\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eBrand\u003c\/th\u003e\n\u003ctd\u003eLumiraDx™\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eManufacturer\u003c\/th\u003e\n\u003ctd\u003eLumiraDx Inc\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eCountry of Origin\u003c\/th\u003e\n\u003ctd\u003eUnknown\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eApplication\u003c\/th\u003e\n\u003ctd\u003eControl Set\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eBuy American Act (BAA) Compliant\u003c\/th\u003e\n\u003ctd\u003eNo\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eContainer Type\u003c\/th\u003e\n\u003ctd\u003eVial\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eFor Use With\u003c\/th\u003e\n\u003ctd\u003eFor use in Conjunction with the LumiraDx SARS-CoV-2 Ag Test Strip System on the LumiraDx Instrument\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eForm\u003c\/th\u003e\n\u003ctd\u003eLiquid\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eLevels\u003c\/th\u003e\n\u003ctd\u003ePositive Level \/ Negative Level\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eProduct Dating\u003c\/th\u003e\n\u003ctd\u003eMcKesson Acceptable Dating: we will ship \u0026gt;= 30 days\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eStorage Requirements\u003c\/th\u003e\n\u003ctd\u003eRequires Refrigeration\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eTest Category\u003c\/th\u003e\n\u003ctd\u003eRespiratory\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eTest Name\u003c\/th\u003e\n\u003ctd\u003eSARS-CoV-2 Ag\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eTest Type\u003c\/th\u003e\n\u003ctd\u003eImmunoassay\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eTrade Agreement Act (TAA) Compliant\u003c\/th\u003e\n\u003ctd\u003eNo\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eUNSPSC Code\u003c\/th\u003e\n\u003ctd\u003e41116128\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eVolume\u003c\/th\u003e\n\u003ctd\u003e4 X 0.5 mL\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-md-6\" tabindex=\"0\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-md-6\" tabindex=\"0\"\u003e\u003c\/div\u003e\n\u003c\/div\u003e","brand":"LumiraDx Inc","offers":[{"title":"Default Title","offer_id":46385517527229,"sku":"MK-1197712","price":139.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0518\/5971\/8333\/files\/1197712_right.jpg?v=1770315870","url":"https:\/\/axiommedicals.com\/products\/immunoassay-control-set-lumiradx%e2%84%a2-sars-cov-2-ag-positive-level-negative-level-4-x-0-5-ml-kit-of-1-mk-1285071-copy","provider":"Axiom Medical Supplies","version":"1.0","type":"link"}