{"product_id":"respiratory-test-kit-inteliswab®-covid-19-rapid-test-otc-2-tests-per-kit-24-kits-per-box-clia-waived-case-of-48-mk-1215558-copy","title":"Respiratory Test Kit LumiraDx™ SARS-CoV-2 Ag 48 Tests KIT OF 1 MK-1285070","description":"\u003cdiv id=\"specifications\" class=\"row fixed-navbar-item\"\u003e\n\u003cdiv class=\"col-lg-12 col-md-12\"\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-md-6\"\u003e\n\u003ch6 id=\"features\"\u003eFeatures\u003c\/h6\u003e\n\u003cul class=\"product-features\"\u003e\n\u003cli\u003eThe LumiraDx SARS-CoV-2 Ag Test is for use under an Emergency Use Authorization 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 263a, that meet the requirements to perform moderate, high or waived complexity tests\u003c\/li\u003e\n\u003cli\u003eProduct ships with minimum 60 days dating\u003c\/li\u003e\n\u003cli\u003eThis test is authorized for use 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\u003eResults are for the identification of SARS-CoV-2 nucleocapsid protein antigen; antigen is generally detectable in nasal swab specimens during the acute phase of infection\u003c\/li\u003e\n\u003cli\u003ePositive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status; positive results do not rule out bacterial infection or co-infection with other viruses\u003c\/li\u003e\n\u003cli\u003eNegative results, from patients with symptoms onset beyond twelve days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed\u003c\/li\u003e\n\u003cli\u003eNegative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions\u003c\/li\u003e\n\u003cli\u003eNegative results should be considered in the context of a patient’s recent exposures, history and presence of clinical signs and symptoms consistent with COVID-19\u003c\/li\u003e\n\u003cli\u003eThe LumiraDx SARS-CoV-2 Ag Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings, and proficient in performing tests using the LumiraDx Instrument\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 diagnostic tests 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\u003eThe workflow process is comprised of a simple sample prep along with step-by-step guidance of the Instrument to report a patient result in under 12 minutes from sample application\u003c\/li\u003e\n\u003cli\u003eThe LumiraDx SARS-CoV-2 Ag test does not differentiate between SARS-CoV and SARS-CoV-2\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2 class=\"page-section h3\" tabindex=\"0\"\u003eProduct Specifications\u003c\/h2\u003e\n\u003chr class=\"bb\"\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-md-6\" tabindex=\"0\"\u003e\n\u003cdiv class=\"table-responsive\"\u003e\n\u003ctable class=\"table table-hover blue\" role=\"presentation\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eMcKesson #\u003c\/th\u003e\n\u003ctd\u003e1285070\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eManufacturer #\u003c\/th\u003e\n\u003ctd\u003e10418176001\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eBrand\u003c\/th\u003e\n\u003ctd\u003eLumiraDx™\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eManufacturer\u003c\/th\u003e\n\u003ctd\u003eRoche Diagnostics\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eCountry of Origin\u003c\/th\u003e\n\u003ctd\u003eUnknown\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eApplication\u003c\/th\u003e\n\u003ctd\u003eRespiratory Test Kit\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eBuy American Act (BAA) Compliant\u003c\/th\u003e\n\u003ctd\u003eNo\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eContents 1\u003c\/th\u003e\n\u003ctd\u003e(48) Individually Packed Test Strips, LumiraDx Test Product Insert, RFID Tag, Dropper Lids, Quick Reference Instructions\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eFor Use With\u003c\/th\u003e\n\u003ctd\u003eFor LumiraDx Platform\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eNumber of Tests\u003c\/th\u003e\n\u003ctd\u003e48 Tests\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eProduct Dating\u003c\/th\u003e\n\u003ctd\u003eMcKesson Acceptable Dating: we will ship \u0026gt;= 60 days\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003ePurchase Program Type\u003c\/th\u003e\n\u003ctd\u003eStandard Purchase\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eReading Type\u003c\/th\u003e\n\u003ctd\u003eMachine Read\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eSample Type\u003c\/th\u003e\n\u003ctd\u003eNasal Swab Sample\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eSpecialty\u003c\/th\u003e\n\u003ctd\u003eImmunoassay\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eStorage Requirements\u003c\/th\u003e\n\u003ctd\u003eRequires Refrigeration\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eTest Format\u003c\/th\u003e\n\u003ctd\u003eTest Strip Format\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eTest Kit Type\u003c\/th\u003e\n\u003ctd\u003eRapid\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eTest Method\u003c\/th\u003e\n\u003ctd\u003eMicrofluidic Immunofluorescence Assay\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eTest Name\u003c\/th\u003e\n\u003ctd\u003eSARS-CoV-2 Ag\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eTest Type\u003c\/th\u003e\n\u003ctd\u003eAntigen Detection\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eTime to Results\u003c\/th\u003e\n\u003ctd\u003e12 Minute Results\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eTrade Agreement Act (TAA) Compliant\u003c\/th\u003e\n\u003ctd\u003eNo\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eUNSPSC Code\u003c\/th\u003e\n\u003ctd\u003e41116144\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv class=\"row\"\u003e\n\u003cdiv class=\"col-md-6\" tabindex=\"0\"\u003e\u003cbr\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"Roche Diagnostics","offers":[{"title":"Default Title","offer_id":46476091556029,"sku":"MK-1285070","price":1213.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0518\/5971\/8333\/files\/1285070_pkgfront.jpg?v=1772821781","url":"https:\/\/axiommedicals.com\/products\/respiratory-test-kit-inteliswab%c2%ae-covid-19-rapid-test-otc-2-tests-per-kit-24-kits-per-box-clia-waived-case-of-48-mk-1215558-copy","provider":"Axiom Medical Supplies","version":"1.0","type":"link"}