{"product_id":"beckman-coulter-reagent-kit-access-r-antibody-test-sars-cov-2-igm-for-use-with-access-family-of-immunoassay-systems-200-tests-kt-1-c58957-kt","title":"Beckman Coulter Reagent Kit Access® Antibody Test SARS-CoV-2 IgM For use with Access Family of Immunoassay Systems 200 Tests - KT\/1 - C58957-KT","description":"\u003ch3\u003eBeckman Coulter Reagent Kit Access® Antibody Test SARS-CoV-2 IgM For use with Access Family of Im...\u003c\/h3\u003e\u003ctable class=\"tblSimple\" summary=\"Product Attributes\"\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eItem Id\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e1172371\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eMF Id#\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eC58957\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\"\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 Well \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e For Use With \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e For use with Access Family of Immunoassay Systems \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 Number of Tests \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e 200 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 Two-step Immunocapture Immunoassay \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Test Name \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e SARS-CoV-2 IgM \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 Time to Results \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e 37 Minute Results \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e UNSPSC Code \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e 41116144 \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 Access SARS-CoV-2 IgM Assay is only for use under the FDA's Emergency Use Authorization: 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 requirements to perform moderate or high complexity tests\u003c\/li\u003e\n\u003cli\u003eAccess SARS%XE2%X80?CoV%XE2%X80?2 IgM is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to SARS%XE2%X80?CoV%XE2%X80?2 in human serum, serum separator tubes and plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, sodium citrate)\u003c\/li\u003e\n\u003cli\u003eAccess SARS%XE2%X80?CoV%XE2%X80?2 IgM is intended for use as an aid in identifying individuals with an adaptive immune response to SARS%XE2%X80?CoV%XE2%X80?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\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 sensitivity of the Access SARS-CoV-2 IgM assay early after infection is unknown; negative results do not preclude acute SARS-CoV-2 infection\u003c\/li\u003e\n\u003cli\u003eFalse positive results for the Access SARS%XE2%X80?CoV%XE2%X80?2 IgM assay may occur due to cross%XE2%X80?reactivity from pre%XE2%X80?existing antibodies or other possible causes; due to the risk of false positive results, confirmation of positive results should be considered using a second different assay\u003c\/li\u003e\n\u003cli\u003eTime-to-first result (approx.): 37 minutes\u003c\/li\u003e\n\u003cli\u003eSample volume: 10uL\u003c\/li\u003e \u003c\/ul\u003e","brand":"Beckman Coulter","offers":[{"title":"Default Title","offer_id":50904797380908,"sku":"C58957-KT","price":2799.99,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.healthcareorigin.com\/products\/beckman-coulter-reagent-kit-access-r-antibody-test-sars-cov-2-igm-for-use-with-access-family-of-immunoassay-systems-200-tests-kt-1-c58957-kt","provider":"Healthcare Origin","version":"1.0","type":"link"}