{"product_id":"roche-real-time-rt-pcr-molecular-control-kit-cobas-r-sars-cov-2-positive-level-negative-level-3-x-0-25-ml-3-x-0-3-ml-kt-1-09408835190-kt","title":"Roche Real Time RT-PCR Molecular Control Kit Cobas® SARS-CoV-2 Positive Level \/ Negative Level 3 X 0.25 mL \/ 3 X 0.3 mL - KT\/1 - 09408835190-KT","description":"\u003ch3\u003eRoche Real Time RT-PCR Molecular Control Kit Cobas® SARS-CoV-2 Positive Level \/ Negative Level 3 ...\u003c\/h3\u003e\u003ctable class=\"tblSimple\" summary=\"Product Attributes\"\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eItem Id\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e1194866\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eMF Id#\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e09408835190\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eBrand\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eCobas®\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eManufacturer\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eRoche\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eCountry of Origin\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eUnited States\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Application \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Molecular Control Kit \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Container Type \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Tube \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e For Use With \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e For Evaluation of the Performance of Nucleic Acid Tests for Determination of Presence of SARS-CoV-2 on the cobas® Liat® Analyzer \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;= 90 days \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Storage Requirements \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Requires Refrigeration \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Test Name \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e SARS-CoV-2 \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Test Type \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Real Time RT-PCR \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e UNSPSC Code \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e 41116145 \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Volume \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e 3 X 0.25 mL \/ 3 X 0.3 mL \u003c\/td\u003e \u003c\/tr\u003e \u003c\/table\u003e \u003ch4 id=\"prodfeats\"\u003eFeatures\u003c\/h4\u003e\u003cul id=\"itemFeatures\" class=\"unordered-list\"\u003e \u003cli\u003ecobas® SARS-CoV-2 is for use under the Emergency Use Authorization (EUA) only: https:\/\/www.fda.gov\/medical-devices\/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2\u003c\/li\u003e\n\u003cli\u003ecobas® SARS-CoV-2 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\u003eIn the United States (US), testing with cobas® SARS-CoV-2 is authorized for 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\u003c\/li\u003e\n\u003cli\u003ePositive results are indicative of the presence of SARS-CoV-2 RNA\u003c\/li\u003e\n\u003cli\u003ePositive results do not rule out bacterial infection or co-infection with other viruses; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status\u003c\/li\u003e\n\u003cli\u003eNegative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions\u003c\/li\u003e\n\u003cli\u003eNegative results must be combined with clinical observations, patient history, and\/or epidemiological information\u003c\/li\u003e\n\u003cli\u003ecobas® SARS-CoV-2 is intended for use by health professionals or trained operators who are proficient in using the cobas Liat System\u003c\/li\u003e\n\u003cli\u003eLaboratories within the U.S. and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities\u003c\/li\u003e\n\u003cli\u003eKit includes: 8 Transfer Pipettes, 1 control kit barcode card, 3 X 0.25 mL Positive Control, 3 X 0.3 mL Dilution UTM\u003c\/li\u003e\n\u003cli\u003eRequires: cobas® Liat® Analyzer (P\/N 07341920190) including cobas® Liat® System Software (Core) Version 3.3 or higher and cobas® SARS CoV-2 Assay Script v1.0 or higher\u003c\/li\u003e \u003c\/ul\u003e","brand":"Roche","offers":[{"title":"Default Title","offer_id":50904587698476,"sku":"09408835190-KT","price":367.99,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.healthcareorigin.com\/products\/roche-real-time-rt-pcr-molecular-control-kit-cobas-r-sars-cov-2-positive-level-negative-level-3-x-0-25-ml-3-x-0-3-ml-kt-1-09408835190-kt","provider":"Healthcare Origin","version":"1.0","type":"link"}