{"product_id":"beckman-coulter-antibody-test-quality-control-access-r-sars-cov-2-igm-level-1-2-3-x-4-ml-per-level-box-of-1-c58959-bx","title":"Beckman Coulter Antibody Test Quality Control Access® SARS-CoV-2 IgM Level 1, 2 3 X 4 mL per Level - Box of 1 - C58959-BX","description":"\u003ch3\u003eBeckman Coulter Antibody Test Quality Control Access® SARS-CoV-2 IgM Level 1, 2 3 X 4 mL per Leve...\u003c\/h3\u003e\u003ctable class=\"tblSimple\" summary=\"Product Attributes\"\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eItem Id\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e1172373\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eMF Id#\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eC58959\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\"\u003eUnited States\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 System Performance of the Access SARS-CoV-2 IgM Assay on the Access Family of Immunoassay Systems only \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 Level 1, 2 \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;= 30 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 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 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 per Level \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\u003eQC1: Negative: TRIS buffer, defibrinated human plasma negative for anti-SARS-CoV-2, surfactant, protein (bovine), \u0026lt; 0.1% sodium azide and 0.5% ProClin* 300\u003c\/li\u003e\n\u003cli\u003eQC2: Positive: TRIS buffer, defibrinated human plasma, human IgM conjugated to anti-SARS-CoV-2 antibodies, surfactant, protein (bovine), \u0026lt; 0.1% sodium azide and 0.5% ProClin 300\u003c\/li\u003e\n\u003cli\u003eThis product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and\/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C.  § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner\u003c\/li\u003e \u003c\/ul\u003e","brand":"Beckman Coulter","offers":[{"title":"Default Title","offer_id":50904798232876,"sku":"C58959-BX","price":874.99,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.healthcareorigin.com\/products\/beckman-coulter-antibody-test-quality-control-access-r-sars-cov-2-igm-level-1-2-3-x-4-ml-per-level-box-of-1-c58959-bx","provider":"Healthcare Origin","version":"1.0","type":"link"}