{"product_id":"respiratory-test-kit-sofia-2-flu-sars-antigen-fia-25-tests-clia-waived","title":"Respiratory Test Kit Sofia 2 Flu + SARS Antigen FIA 25 Tests CLIA Waived","description":"\u003cul\u003e\n\u003cli\u003eFor use on Sofia 2 analyzers ONLY - test cannot be run on a Sofia 1 analyzer; reach out to your account manager with any analyzer questions or requests\u003c\/li\u003e\n\u003cli\u003eSofia 2 Flu + SARS Antigen FIA is for use under an FDA EUA:\u003c\/li\u003e\n\u003cli\u003eProduct ships with minimum 60 days dating\u003c\/li\u003e\n\u003cli\u003eEmergency use of this test 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 high, moderate or waived complexity tests\u003c\/li\u003e\n\u003cli\u003eThis test is only authorized 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner\u003c\/li\u003e\n\u003cli\u003eThe Sofia 2 Flu + SARS FIA is intended to be used with direct nasal or nasopharyngeal swabs and is not validated for use with viral transport media\u003c\/li\u003e\n\u003cli\u003eThe test is intended for use in the simultaneous rapid in vitro detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus nucleocapsid protein antigen , but does not differentiate, between SARS-CoV and SARS-CoV-2 viruses and is not intended to detect influenza C antigens\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\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 SARS-CoV-2results to the appropriate public health authorities\u003c\/li\u003e\n\u003cli\u003eNegative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions; negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19\u003c\/li\u003e\n\u003cli\u003eNegative SARS-CoV-2 results, from patients with symptom onset beyond five 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\u003eThe Sofia 2 Flu + SARS Antigen FIA is intended for use on the Sofia 2 only and by medical professionals or trained operators who are proficient in performing tests using the Sofia 2 Instrument; the Sofia 2 Flu + SARS Antigen FIA test is only for use under the Food and Drug Administration’s Emergency Use Authorization\u003c\/li\u003e\n\u003cli\u003eAccurate detection with direct samples\u003c\/li\u003e\n\u003cli\u003eResults in 15 minutes\u003c\/li\u003e\n\u003cli\u003e12-month shelf life from date of manufacture\u003c\/li\u003e\n\u003cli\u003eThis test is only authorized 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner\u003c\/li\u003e\n\u003cli\u003eRoom temperature storage\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\u003e1177399\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eCatalog Number\u003c\/th\u003e\n\u003ctd\u003e20377\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eUOM\u003c\/th\u003e\n\u003ctd\u003eCS\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eLevel 1 Family Description\u003c\/th\u003e\n\u003ctd\u003eLab-Waived Lab\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eLevel 2 Category Description\u003c\/th\u003e\n\u003ctd\u003eLab-Respiratory Testing\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eLevel 3 Group Description\u003c\/th\u003e\n\u003ctd\u003eCombo Tests\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eLevel 4 Sub-Category Description\u003c\/th\u003e\n\u003ctd\u003eFlu-COVID Reader Testing\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eApplication\u003c\/th\u003e\n\u003ctd\u003eRespiratory Test Kit\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eBrand\u003c\/th\u003e\n\u003ctd\u003eSofia 2\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eBuy American Act (BAA) Compliant\u003c\/th\u003e\n\u003ctd\u003eYes\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eCLIA Classification\u003c\/th\u003e\n\u003ctd\u003eCLIA Waived\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eCLIA Classified\u003c\/th\u003e\n\u003ctd\u003eCLIA Waived\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eContents 1\u003c\/th\u003e\n\u003ctd\u003e(25) Individually Packaged Test Cassettes, (25) Reagent Tubes, (25) Ampoules of Reagent Solution, (25) Sterile Nasal Swabs, (25) X 120 µL Fixed Volume Pipettes, Flu + SARS Positive Control Swab, Negative Control Swab, Package Insert, Quick Reference Instructions, QC Card\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eCountry of Origin\u003c\/th\u003e\n\u003ctd\u003eUnited States\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eFor Use With\u003c\/th\u003e\n\u003ctd\u003eFor use with Sofia 2 Fluorescent Immunoassay Analyzer\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eIs_ECAT\u003c\/th\u003e\n\u003ctd\u003eN\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eIs_GSA\u003c\/th\u003e\n\u003ctd\u003eY\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eIs_VA\u003c\/th\u003e\n\u003ctd\u003eN\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eManufacturer\u003c\/th\u003e\n\u003ctd\u003eQuidel\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eManufacturer #\u003c\/th\u003e\n\u003ctd\u003e20377\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eMcKesson #\u003c\/th\u003e\n\u003ctd\u003e1177399\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eNumber of Tests\u003c\/th\u003e\n\u003ctd\u003e25 Tests\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003ePurchase Program Type\u003c\/th\u003e\n\u003ctd\u003eStandard Purchase\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eReading Type\u003c\/th\u003e\n\u003ctd\u003eMachine Read\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eSample Type\u003c\/th\u003e\n\u003ctd\u003eNasal Swab Sample\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eSpecialty\u003c\/th\u003e\n\u003ctd\u003eImmunoassay\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eTest Format\u003c\/th\u003e\n\u003ctd\u003eCassette Format\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eTest Kit Type\u003c\/th\u003e\n\u003ctd\u003eRapid\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eTest Name\u003c\/th\u003e\n\u003ctd\u003eFlu + SARS Antigen FIA\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eTest Type\u003c\/th\u003e\n\u003ctd\u003eFluorescence Immunoassay (FIA)\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eTime to Results\u003c\/th\u003e\n\u003ctd\u003e15 Minute Results\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eTrade Agreement Act (TAA) Compliant\u003c\/th\u003e\n\u003ctd\u003eYes\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eUNSPSC Code\u003c\/th\u003e\n\u003ctd\u003e41116144\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\u003c\/table\u003e","brand":"Quidel","offers":[{"title":"Default Title","offer_id":42967753424973,"sku":"QDE-20377","price":7554.13,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1046\/1086\/files\/1177399_pkgright.jpg?v=1780343138","url":"https:\/\/mfimedical.com\/products\/respiratory-test-kit-sofia-2-flu-sars-antigen-fia-25-tests-clia-waived","provider":"MFI Medical","version":"1.0","type":"link"}