{"product_id":"respiratory-test-kit-cordx-tyfast-respiratory-syncytial-virus-test-rsv-25-tests-clia-waived-box-of-25-mk-1283266-copy","title":"Respiratory Test Kit FaStep® Covid-19 Antigen Pen Home Test 2 Tests per Pack, CASE OF 96 MK-1273391","description":"\u003ch6 id=\"features\"\u003eFeatures\u003c\/h6\u003e\n\u003cul class=\"product-features\"\u003e\n\u003cli\u003eThe Fastep COVID-19 Antigen Pen Home Test is for FDA Emergency Use Authorization (EUA) only: https:\/\/www.fda.gov\/medical-devices\/covid-19-emergency-use-authorizations-medical-devices\/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2\u003c\/li\u003e\n\u003cli\u003eFastep COVID-19 Antigen Pen Home Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus\u003c\/li\u003e\n\u003cli\u003eThis test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult collected anterior nasal (nares) swab samples from individuals aged two (2) years or older\u003c\/li\u003e\n\u003cli\u003eThis test is authorized for individuals with symptoms of COVID-19 within the first 6 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when tested at least three times over five days with at least 48 hours between tests\u003c\/li\u003e\n\u003cli\u003ePositive results indicate the presence of viral antigens, but clinical correlation with past medical 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\u003eAll negative results are 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 measures such as isolating from others and wearing masks; negative results should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19\u003c\/li\u003e\n\u003cli\u003eAll healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC\u003c\/li\u003e\n\u003cli\u003eThe Fastep® COVID-19 Antigen Pen Home Test is a single test comprised of a base and a test pen with an integrated sample swab and test strip\u003c\/li\u003e\n\u003cli\u003eEach Fastep® COVID-19 Antigen Pen Home Test has a built-in internal procedural control\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\u003e1273391\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eManufacturer #\u003c\/th\u003e\n\u003ctd\u003eCOV-S35001H2\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eBrand\u003c\/th\u003e\n\u003ctd\u003eFaStep®\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eManufacturer\u003c\/th\u003e\n\u003ctd\u003e2San LLC\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\u003eEach Kit contains (2) Foil Packages with Base and Test Pen, Package Insert\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\u003e2 Tests per Pack\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;= 90 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\u003eVisual 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\u003eAnterior Nasal (Nares) 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\"\u003eTest Format\u003c\/th\u003e\n\u003ctd\u003eTest Device 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\u003eLateral Flow\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eTest Name\u003c\/th\u003e\n\u003ctd\u003eCovid-19 Antigen Pen Home Test\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eTest Type\u003c\/th\u003e\n\u003ctd\u003eHome Test Device\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\u003e15 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\u003c\/div\u003e\n\u003c\/div\u003e","brand":"2San LLC","offers":[{"title":"Default Title","offer_id":46472479604925,"sku":"MK-1273391","price":797.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0518\/5971\/8333\/files\/1273391_kit.jpg?v=1772739614","url":"https:\/\/axiommedicals.com\/products\/respiratory-test-kit-cordx-tyfast-respiratory-syncytial-virus-test-rsv-25-tests-clia-waived-box-of-25-mk-1283266-copy","provider":"Axiom Medical Supplies","version":"1.0","type":"link"}