{"product_id":"immunoassay-control-set-lumiradx-sars-cov-2-ag-positive-level-negative-level-4-x-0-5-ml","title":"Immunoassay Control Set LumiraDx SARS-CoV-2 Ag Positive Level \/ Negative Level 4 X 0.5 mL","description":"\u003cul\u003e\n\u003cli\u003eThe LumiraDx SARS-CoV-2 Ag Test is for use under an Emergency Use Authorization ONLY:\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\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\u003eThe LumiraDx SARS-CoV-2 Ag test does not differentiate between SARS-CoV and SARS-CoV-2\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\u003eThe LumiraDx SARS-CoV-2 Ag Quality Controls (hereafter referred to as Quality Controls) are liquid quality controls to be used with the LumiraDx Instrument (hereafter referred to as the Instrument) and the LumiraDx SARS-CoV-2 Ag Test (hereafter referred to as SARS-CoV-2 Ag Test)\u003c\/li\u003e\n\u003cli\u003eThe LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip\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\u003eKit contents: 2 X 0.5ml vial SARS-CoV-2 Ag Positive Control, 2 X 0.5ml vial SARS-CoV-2 Ag Negative Control, 24 Transfer pipettes (20µl), LumiraDx SARS-CoV-2 Ag Quality Control Pack Insert\u003c\/li\u003e\n\u003cli\u003eRequires: LumiraDx Instrument, LumiraDx SARS-CoV-2 Ag Test Strips, and LumiraDx Connect– if connectivity required (refer to LumiraDx Connect User Manual)\u003c\/li\u003e\n\u003c\/ul\u003e\u003ch3\u003eProduct Specs\u003c\/h3\u003e\u003ctable\u003e\u003ctbody\u003e\n\u003ctr\u003e\n\u003cth\u003eItem Number\u003c\/th\u003e\n\u003ctd\u003e1176896\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eCatalog Number\u003c\/th\u003e\n\u003ctd\u003eL016080109002\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eUOM\u003c\/th\u003e\n\u003ctd\u003eEA\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eLevel 1 Family Description\u003c\/th\u003e\n\u003ctd\u003eLab-Non-Waived Lab\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eLevel 2 Category Description\u003c\/th\u003e\n\u003ctd\u003eLab-Immunoassay\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eLevel 3 Group Description\u003c\/th\u003e\n\u003ctd\u003eImmunoassay Reagents\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eLevel 4 Sub-Category Description\u003c\/th\u003e\n\u003ctd\u003eCOVID - IA Cals\/Ctrls\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eApplication\u003c\/th\u003e\n\u003ctd\u003eControl Set\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eBrand\u003c\/th\u003e\n\u003ctd\u003eLumiraDx\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eBuy American Act (BAA) Compliant\u003c\/th\u003e\n\u003ctd\u003eNo\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eContainer Type\u003c\/th\u003e\n\u003ctd\u003eVial\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eCountry of Origin\u003c\/th\u003e\n\u003ctd\u003eUnknown\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eFor Use With\u003c\/th\u003e\n\u003ctd\u003eFor use in Conjunction with the LumiraDx SARS-CoV-2 Ag Test Strip System on the LumiraDx Instrument\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eForm\u003c\/th\u003e\n\u003ctd\u003eLiquid\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eLevels\u003c\/th\u003e\n\u003ctd\u003ePositive Level \/ Negative Level\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eManufacturer\u003c\/th\u003e\n\u003ctd\u003eLumiraDx Inc\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eManufacturer #\u003c\/th\u003e\n\u003ctd\u003eL016080109002\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eMcKesson #\u003c\/th\u003e\n\u003ctd\u003e1197712\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eStorage Requirements\u003c\/th\u003e\n\u003ctd\u003eRequires Refrigeration\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eTest Category\u003c\/th\u003e\n\u003ctd\u003eRespiratory\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eTest Name\u003c\/th\u003e\n\u003ctd\u003eSARS-CoV-2 Ag\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eTest Type\u003c\/th\u003e\n\u003ctd\u003eImmunoassay\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eTrade Agreement Act (TAA) Compliant\u003c\/th\u003e\n\u003ctd\u003eNo\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eUNSPSC Code\u003c\/th\u003e\n\u003ctd\u003e41116128\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eVolume\u003c\/th\u003e\n\u003ctd\u003e4 X 0.5 mL\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\u003c\/table\u003e","brand":"LumiraDx Inc","offers":[{"title":"Default Title","offer_id":42969095209037,"sku":"LDX-L016080109002","price":64.98,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1046\/1086\/files\/1197712_right.jpg?v=1780292920","url":"https:\/\/mfimedical.com\/products\/immunoassay-control-set-lumiradx-sars-cov-2-ag-positive-level-negative-level-4-x-0-5-ml","provider":"MFI Medical","version":"1.0","type":"link"}