{"product_id":"roche-molecular-diagnostic-rt-pcr-molecular-control-kit-cobas-r-liat-r-sars-cov-2-and-influenza-a-b-positive-level-negative-level-3-x-0-25-ml-3-x-10-aul-3-x-0-3-ml-kt-1-09211128190-kt","title":"Roche Molecular Diagnostic \/ RT-PCR Molecular Control Kit Cobas® Liat® SARS-CoV-2 and Influenza A \/ B Positive Level \/ Negative Level 3 X 0.25 mL \/ 3 X 10 µL \/ 3 X 0.3 mL - KT\/1 - 09211128190-KT","description":"\u003ch3\u003eRoche Molecular Diagnostic \/ RT-PCR Molecular Control Kit Cobas® Liat® SARS-CoV-2 and Influenza A...\u003c\/h3\u003e\u003ctable class=\"tblSimple\" summary=\"Product Attributes\"\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eItem Id\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e1177912\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eMF Id#\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e09211128190\u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003eBrand\u003c\/td\u003e \u003ctd class=\"attrDat\"\u003eCobas® Liat®\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 For Use With \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e For use with cobas® SARS-CoV-2 and Influenza Nucleic Acid Test on the cobas® Liat® System \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Form \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Liquid \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;= 30 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 and Influenza A \/ B \u003c\/td\u003e \u003c\/tr\u003e \u003ctr\u003e \u003ctd class=\"attrTitle\"\u003e Test Type \u003c\/td\u003e \u003ctd class=\"attrDat\"\u003e Molecular Diagnostic \/ 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 10  µL \/ 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\u003eThe cobas SARS-CoV-2 \u0026amp; Influenza A\/B Nucleic Acid Test is for use on the cobas Liat System under FDA Emergency Use Authorization: https:\/\/www.fda.gov\/medical-devices\/emergency-situations-medical-devices\/emergency-use-authorizations\u003c\/li\u003e\n\u003cli\u003eEmergency use of this test is limited to authorized laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.  §263a, to perform moderate or high complexity tests\u003c\/li\u003e\n\u003cli\u003eThe cobas SARS-CoV-2 \u0026amp; Influenza A\/B Nucleic Acid Test for use on the cobas Liat System is also 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 new cobas SARS-CoV-2 \u0026amp; Influenza A\/B test analyzes nucleic acids from nasopharyngeal and nasal swab samples and self-collected nasal swabs (collected in a healthcare setting with instruction by a healthcare provider) to enable frontline healthcare workers to quickly identify and differentiate these similarly presenting infections\u003c\/li\u003e\n\u003cli\u003eThis test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, and influenza B virus and not for any other viruses or pathogens\u003c\/li\u003e\n\u003cli\u003eThis test is only authorized in the United States 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\u003ePositive results are indicative of active infection but do not rule out bacterial infection or co-infection with other pathogens not detected by the test; 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, influenza A, and\/or influenza B 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 \u0026amp; Influenza A\/B is intended for use by health professionals or trained operators who are proficient in using the cobas® Liat System\u003c\/li\u003e\n\u003cli\u003eIncludes: 11 Transfer Pipettes and 1 Control Kit Barcode Card\u003c\/li\u003e\n\u003cli\u003e3 X 0.25 mL SARS-Cov-2 (+), 3 X 10  µL FLU A\/B (+), 3 X 0.3 mL Dilution UTM (-)\u003c\/li\u003e \u003c\/ul\u003e","brand":"Roche","offers":[{"title":"Default Title","offer_id":50904533008684,"sku":"09211128190-KT","price":367.99,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.healthcareorigin.com\/products\/roche-molecular-diagnostic-rt-pcr-molecular-control-kit-cobas-r-liat-r-sars-cov-2-and-influenza-a-b-positive-level-negative-level-3-x-0-25-ml-3-x-10-aul-3-x-0-3-ml-kt-1-09211128190-kt","provider":"Healthcare Origin","version":"1.0","type":"link"}