{"product_id":"ortho-clinical-diagnostics-antibody-test-control-kit-vitros-r-anti-sars-cov-2-igg-positive-level-negative-level-6-x-1-ml-each-6199921-ea","title":"Ortho Clinical Diagnostics Antibody Test Control Kit Vitros® Anti-SARS-CoV-2 IgG Positive Level \/ Negative Level 6 X 1 mL - Each - 6199921-EA","description":"\u003ch3\u003eOrtho Clinical Diagnostics Antibody Test Control Kit Vitros® Anti-SARS-CoV-2 IgG Positive Level \/...\u003c\/h3\u003e\u003ctable class=\"tblSimple\" summary=\"Product Attributes\"\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eItem Id\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e1166248\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eMF Id#\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e6199921\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eBrand\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eVitros®\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eManufacturer\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eOrtho Clinical Diagnostics\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eCountry of Origin\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eUnited Kingdom\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Application \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Control Kit \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 use in Monitoring the Performance of the Vitros Immunodiagnostic and Integrated Systems when used for the Determination of IgG Antibodies to SARS-CoV-2 \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Form \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Liquid \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 Anti-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 6 X 1 mL \u003c\/td\u003e \u003c\/tr\u003e \u003c\/table\u003e \u003ch4 id=\"prodfeats\"\u003eFeatures\u003c\/h4\u003e\u003cul id=\"itemFeatures\" class=\"unordered-list\"\u003e \u003cli\u003eFor use under an Emergency Use Authorization (EUA) 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. section 263a, to perform moderate and high complexity tests\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\u003eThe sensitivity of VITROS Anti-SARS-CoV-2 IgG test in early infection is unknown; negative 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 VITROS Anti-SARS-CoV-2 IgG test may occur due to cross-reactivity from pre-existing antibodies or other possible causes\u003c\/li\u003e\n\u003cli\u003eVITROS Anti‑SARS-CoV-2 IgG Controls 1 and 2 contain: SARS-CoV-2 IgG negative plasma obtained from donors who were tested individually and who were found to be negative for hepatitis B surface antigen, and for antibodies to hepatitis C virus (HCV) and HIV, using approved methods (enzyme immunoassays\u003c\/li\u003e\n\u003cli\u003eVITROS Anti-SARS-CoV-2 IgG Control 2 in addition contains: SARS-CoV2 IgG - no testing method can rule out the risk of potential infection, handle as if capable of transmitting infection\u003c\/li\u003e\n\u003cli\u003eVITROS Anti-SARS-CoV-2 IgG Controls are suitable for use until the expiration date on the carton when stored and handled as specified; do not use beyond the expiration date\u003c\/li\u003e\n\u003cli\u003eVITROS Anti-SARS-CoV-2 IgG Control 1 should generate Non-reactive (Negative) results\u003c\/li\u003e\n\u003cli\u003eVITROS Anti-SARS-CoV-2 IgG Control 2 should generate Reactive (Positive) results\u003c\/li\u003e\n\u003cli\u003eKit contains: 3 sets of VITROS Anti-SARS-CoV-2 IgG Controls 1 and 2 (human matrix with anti-microbial agent, 1 mL)\u003c\/li\u003e\n\u003cli\u003eRx ONLY; for in vitro diagnostic and Laboratory Professional use\u003c\/li\u003e\n\u003cli\u003eSupplied ready to use\u003c\/li\u003e \u003c\/ul\u003e","brand":"Ortho Clinical Diagnostics","offers":[{"title":"Default Title","offer_id":50904781029676,"sku":"6199921-EA","price":639.99,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.healthcareorigin.com\/products\/ortho-clinical-diagnostics-antibody-test-control-kit-vitros-r-anti-sars-cov-2-igg-positive-level-negative-level-6-x-1-ml-each-6199921-ea","provider":"Healthcare Origin","version":"1.0","type":"link"}