{"product_id":"beckman-coulter-antibody-test-quality-control-access-r-sars-cov-2-igg-positive-level-negative-level-3-x-4-ml-m-1167488-2428-box-of-1","title":"Beckman Coulter Antibody Test Quality Control Access® SARS-CoV-2 IgG Positive Level \/ Negative Level 3 X 4 mL - M-1167488-2428 - Box of 1","description":"\u003cp\u003e\u003cspan style=\"color: #ff0000;\"\u003e\u003cstrong\u003eItem is Non - Returnable\u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\u003ch3\u003e\u003cstrong\u003e\u003cspan style=\"color: #ff0000;\"\u003eDelivery - 7-10 Days, Ship Directly from Manufacturer\u003c\/span\u003e\u003c\/strong\u003e\u003c\/h3\u003e\u003cli\u003eThe Access SARS-CoV-2 IgG assay is only for use under the Food and Drug Administration's Emergency Use Authorization: https:\/\/www.fda.gov\/medical-devices\/emergency-situations-medical-devices\/emergency-use-authorizations\u003c\/li\u003e \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 moderate or high complexity tests\u003c\/li\u003e \u003cli\u003eThe Access SARS-CoV-2 IgG assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection; at this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity\u003c\/li\u003e \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 \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 \u003cli\u003eFalse positive results for the Access SARS-CoV-2 IgG assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes\u003c\/li\u003e \u003cli\u003eProvided ready to use\u003c\/li\u003e \u003cli\u003eRefer to the QC value card for mean values and standard deviations (SD)\u003c\/li\u003e \u003cli\u003eQC1: Negative: TRIS buffer, defibrinated human plasma negative for anti-SARS-CoV-2 surfactant and protein (bovine), \u0026lt; 0.1% sodium azide and 0.5% ProClin 300\u003c\/li\u003e \u003cli\u003eQC2: Positive: TRIS buffer, defibrinated human plasma containing anti-SARS-CoV-2 IgG, surfactant and protein (bovine), \u0026lt; 0.1% sodium azide and 0.5% ProClin 300\u003c\/li\u003e\u003cbr\u003e \u003ctable class=\"tblSimple\" summary=\"Product Attributes\"\u003e\u003ctbody\u003e  \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003eItem Id\u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e1167488\u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003eMF ID\u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003eC58964\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\"\u003e Application \u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e Quality Control \u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003e Container Type \u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e Vial \u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003e For Use With \u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e For Monitoring Performance of Access SARS-CoV-2 IgG Assay on the Access Family of Immunoassay Systems \u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003e Levels \u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e Positive Level \/ Negative Level \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 Storage Requirements \u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e Requires Refrigeration \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 \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 41116145 \u003c\/td\u003e   \u003c\/tr\u003e   \u003ctr\u003e    \u003ctd class=\"attrTitle\"\u003e Volume \u003c\/td\u003e    \u003ctd class=\"attrDat\"\u003e 3 X 4 mL \u003c\/td\u003e   \u003c\/tr\u003e  \u003c\/tbody\u003e\u003c\/table\u003e","brand":"Beckman Coulter","offers":[{"title":"Box of 1","offer_id":39988297760957,"sku":"M-1167488-2428","price":785.99,"currency_code":"USD","in_stock":true}],"url":"https:\/\/axiommedicals.com\/products\/beckman-coulter-antibody-test-quality-control-access-r-sars-cov-2-igg-positive-level-negative-level-3-x-4-ml-m-1167488-2428-box-of-1","provider":"Axiom Medical Supplies","version":"1.0","type":"link"}