{"product_id":"respiratory-test-kit-osom-covid-19-antigen-40-tests","title":"Respiratory Test Kit OSOM COVID-19 Antigen 40 Tests","description":"\u003cul\u003e\n\u003cli\u003eOSOM Covid-19 Antigen Rapid Test is for use under an FDA EUA:\u003c\/li\u003e\n\u003cli\u003eOSOM COVID-19 Antigen Rapid Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct midturbinate (MT) nasal swab specimens from individuals who are suspected of COVID-19\u003c\/li\u003e\n\u003cli\u003eQualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct mid-turbinate (MT) nasal swab specimens collected by a healthcare provider from individuals suspected of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests and from 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\u003eFor laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests\u003c\/li\u003e\n\u003cli\u003eThis test 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\u003ePositive results indicate the presence of viral antigens, but clinical correlation with past medical 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\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\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\u003e1232792\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eCatalog Number\u003c\/th\u003e\n\u003ctd\u003e1066-40\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\u003eCOVID Testing\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eLevel 4 Sub-Category Description\u003c\/th\u003e\n\u003ctd\u003eCOVID - Rapids\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\u003eOSOM\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eBuy American Act (BAA) Compliant\u003c\/th\u003e\n\u003ctd\u003eNo\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eContents 1\u003c\/th\u003e\n\u003ctd\u003e(40) Test Devices containing LFI Test Strip in Plastic Housing, 2 X (20) Nasal Swab Specimen Collection and Dispensing Tubes with OSOM Antigen Buffer, IFU, Quick Ref Guide\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eCountry of Origin\u003c\/th\u003e\n\u003ctd\u003eUnknown\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\u003eSekisui Diagnostics\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eManufacturer #\u003c\/th\u003e\n\u003ctd\u003e1066-40\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eMcKesson #\u003c\/th\u003e\n\u003ctd\u003e1232792\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eNumber of Tests\u003c\/th\u003e\n\u003ctd\u003e40 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\u003eVisual Read\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eSample Type\u003c\/th\u003e\n\u003ctd\u003eDirect Mid-Turbinate Nasal 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\u003eTest Device 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 Method\u003c\/th\u003e\n\u003ctd\u003eLateral Flow Chromatographic Immunassay\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003cth\u003eTest Name\u003c\/th\u003e\n\u003ctd\u003eCOVID-19 Antigen\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\u003eNo\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":"Sekisui Diagnostics","offers":[{"title":"Default Title","offer_id":42967596728397,"sku":"SEK-1066-40","price":3079.26,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1046\/1086\/files\/1232792_pkit.jpg?v=1780315271","url":"https:\/\/mfimedical.com\/products\/respiratory-test-kit-osom-covid-19-antigen-40-tests","provider":"MFI Medical","version":"1.0","type":"link"}