{"product_id":"respiratory-test-kit-solana®-sars-cov-2-48-tests-clia-non-waived-kit-of-48-mk-1209944-copy","title":"Respiratory Test Kit Solana® SARS-CoV-2 48 Tests CLIA Non-Waived KIT OF 48 MK-1209945","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\u003eSolana SARS-CoV-2 Assay is for use under an FDA 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, to perform high or moderate complexity tests\u003c\/li\u003e\n\u003cli\u003eThe Solana SARS-CoV-2 Assay is an isothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens from individuals suspected of COVID-19 by their healthcare provider\u003c\/li\u003e\n\u003cli\u003ePositive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status\u003c\/li\u003e\n\u003cli\u003ePositive results do not rule out bacterial infection or co-infection with other viruses\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\u003eNegative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions; negative results must be combined with clinical observations, patient history, and epidemiological information\u003c\/li\u003e\n\u003cli\u003eThe Solana SARS-CoV-2 Assay is intended for use by laboratory personnel who have received specific training on the use of the Solana SARS-CoV-2 Assay and\/or the Solana Instrument\u003c\/li\u003e\n\u003cli\u003eThe assay consists of two major steps: (1) specimen preparation, and (2) amplification and detection of target sequences specific to SARS-CoV-2 using isothermal Reverse Transcriptase — Helicase-Dependent Amplification (RT-HDA) in the presence of target-specific fluorescence probes which is performed in the Solana instrument\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\u003e1209945\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eManufacturer #\u003c\/th\u003e\n\u003ctd\u003eM960\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eBrand\u003c\/th\u003e\n\u003ctd\u003eSolana®\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eManufacturer\u003c\/th\u003e\n\u003ctd\u003eQuidel\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\u003eUnited States\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\u003eYes\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eCLIA Classification\u003c\/th\u003e\n\u003ctd\u003eCLIA Non-Waived\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eCLIA Classified\u003c\/th\u003e\n\u003ctd\u003eCLIA Non-Waived\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) Tests, Controls, (50) Nasopharyngeal Swabs, (50) Universal Transport Media\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 use with Solana Instrument\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eHCPCS\u003c\/th\u003e\n\u003ctd\u003eU0002\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eIs_ECAT\u003c\/th\u003e\n\u003ctd\u003eN\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eIs_GSA\u003c\/th\u003e\n\u003ctd\u003eY\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eIs_VA\u003c\/th\u003e\n\u003ctd\u003eN\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;= 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\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 \/ Nasopharyngeal 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\u003eMolecular\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\u003eTube 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\u003eIsothermal Reverse Transcriptase - Helicase-Dependent Amplification (RT-HDA) 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\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth scope=\"row\" class=\"text-nowrap\"\u003eTest Type\u003c\/th\u003e\n\u003ctd\u003eMolecular Diagnostic\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\u003e25 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\u003eYes\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\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"Quidel","offers":[{"title":"Default Title","offer_id":46476157354173,"sku":"MK-1209945","price":2591.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0518\/5971\/8333\/files\/1209945_pkgright.jpg?v=1772824501","url":"https:\/\/axiommedicals.com\/products\/respiratory-test-kit-solana%c2%ae-sars-cov-2-48-tests-clia-non-waived-kit-of-48-mk-1209944-copy","provider":"Axiom Medical Supplies","version":"1.0","type":"link"}