{"product_id":"abbott-antibody-test-control-kit-advisedx-sars-cov-2-igg-ii-level-1-positive-level-2-positive-negative-level-3-x-4-ml-kt-1-06s6110-kt","title":"Abbott Antibody Test Control Kit AdviseDx SARS-CoV-2 IgG II Level 1 Positive, Level 2 Positive, Negative Level 3 X 4 mL - KT\/1 - 06S6110-KT","description":"\u003ch3\u003eAbbott Antibody Test Control Kit AdviseDx SARS-CoV-2 IgG II Level 1 Positive, Level 2 Positive, N...\u003c\/h3\u003e\u003ctable class=\"tblSimple\" summary=\"Product Attributes\"\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eItem Id\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e1187910\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eMF Id#\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e06S6110\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 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 the Estimation of Test Precision and the Detection of Systematic Analytical Deviations of the Alinity i System when used for the Qualitative and Semi-Quantitative Detection of IgG Antibodies to SARS-CoV-2 in Human Serum \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Is_Active_Vendor \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Y \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Is_DSCSA \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e N \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Is_Discontinued \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e N \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Is_Medical_Device \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e N \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Levels \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Level 1 Positive, Level 2 Positive, Negative Level \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Lot_Tracking_Flag \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e N \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e On_Allocation \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e N \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 Keep Frozen \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Supplier_ID \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e 4446496 \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 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\/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 for use under an Emergency Use Authorization Only: https:\/\/www.fda.gov\/medical-devices\/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\/in-vitro-diagnostics-euas#individual-serological\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 (including collected using a serum separator tube) and plasma (acid citrate dextrose, sodium citrate, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin in a separator tube, and sodium heparin) on the Alinity i system\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\u003eA positive result may not indicate previous SARS-CoV-2 infection; consider other information, including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an immune response\u003c\/li\u003e\n\u003cli\u003eA negative result for an individual subject indicates the absence of detectable anti-SARS CoV-2 antibodies; Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions\u003c\/li\u003e\n\u003cli\u003eA negative result can occur if the quantity of the anti-SARS-CoV-2 antibodies in the specimen is below the detection limits of the assay, or if the antibodies are not present during the stage of disease in which a sample is collected\u003c\/li\u003e\n\u003cli\u003eThe AdviseDx SARS-CoV-2 IgG II Control Kit is for the estimation of test precision and the detection of systematic analytical deviations of the Alinity i system when used for the qualitative and semi quantitative detection of IgG antibodies to SARS-CoV-2 in human serum (including collected using a serum separator tube) and plasma (acid citrate dextrose, sodium citrate, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin in a separator tube, and sodium heparin)\u003c\/li\u003e\n\u003cli\u003eNegative control contains negative human plasma\u003c\/li\u003e\n\u003cli\u003ePositive control 1 and positive control 2 contain SARS-CoV-2 IgG positive human plasma\u003c\/li\u003e \u003c\/ul\u003e","brand":"Abbott","offers":[{"title":"Default Title","offer_id":50904817893676,"sku":"06S6110-KT","price":423.99,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.healthcareorigin.com\/products\/abbott-antibody-test-control-kit-advisedx-sars-cov-2-igg-ii-level-1-positive-level-2-positive-negative-level-3-x-4-ml-kt-1-06s6110-kt","provider":"Healthcare Origin","version":"1.0","type":"link"}