{"product_id":"premier-biotech-antibody-test-control-kit-assure-tech-covid-19-igg-igm-positive-level-negative-level-kt-1-az-ctrl-cw-kt","title":"Premier Biotech Antibody Test Control Kit Assure Tech COVID-19 IgG \/ IgM Positive Level \/ Negative Level - KT\/1 - AZ-CTRL-CW-KT","description":"\u003ch3\u003ePremier Biotech Antibody Test Control Kit Assure Tech COVID-19 IgG \/ IgM Positive Level \/ Negativ...\u003c\/h3\u003e\u003ctable class=\"tblSimple\" summary=\"Product Attributes\"\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eItem Id\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e1179103\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eMF Id#\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eAZ-CTRL-CW\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eBrand\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eAssure Tech\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eManufacturer\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003ePremier Biotech\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eCountry of Origin\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eChina\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 with Assure COVID-19 IgG \/ IgM Assay \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Form \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Powder \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;= 30 days \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Storage Requirements \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e USP Controlled Room Temperature \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Test Name \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e COVID-19 IgG \/ 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 41116128 \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 Assure COVID-19 IgG\/IgM Rapid Test Device is for use under FDA Emergency Use Authorization: https:\/\/www.fda.gov\/medical-devices\/emergency-situations-medical-devices\/emergency-use-authorizations\u003c\/li\u003e\n\u003cli\u003eUse of this test with all authorized specimen types 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; this test is also authorized for use with fingerstick whole blood specimens only at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation\u003c\/li\u003e\n\u003cli\u003eAssure COVID-19 IgG\/IgM Control is intended to be used as external quality control material for the Assure COVID-19 IgG\/IgM Rapid Test Device; the control can be used to verify proper performance of COVID-19 IgG\/IgM Rapid Test kit\u003c\/li\u003e\n\u003cli\u003eThe Assure COVID-19 IgG\/IgM Rapid Test Device 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\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\u003eFalse positive results for Assure COVID-19 IgG\/IgM Rapid Test Device may occur due to cross-reactivity from pre-existing antibodies or other possible causes\u003c\/li\u003e\n\u003cli\u003eDue to the risk of false positive results, confirmation of positive results should be considered using second, different IgG or IgM assay\u003c\/li\u003e\n\u003cli\u003eThis test 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C.  § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner\u003c\/li\u003e\n\u003cli\u003eNegative controls are lyophilized human serum samples and positive controls are lyophilized IgG and IgM against SARS-CoV-2\u003c\/li\u003e\n\u003cli\u003e2 Vials Neg \/ 1 Vial Pos allow for total 5 positive QC tests and 5 negative QC tests\u003c\/li\u003e \u003c\/ul\u003e","brand":"Premier Biotech","offers":[{"title":"Default Title","offer_id":50904686428460,"sku":"AZ-CTRL-CW-KT","price":129.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0927\/7089\/4124\/files\/1179103_ppkg.jpg?v=1744075643","url":"https:\/\/www.healthcareorigin.com\/products\/premier-biotech-antibody-test-control-kit-assure-tech-covid-19-igg-igm-positive-level-negative-level-kt-1-az-ctrl-cw-kt","provider":"Healthcare Origin","version":"1.0","type":"link"}