Abbott Rapid Dx North America LLC #195000 Rapid Test Kit BinaxNOW™ Professional Use Antigen Detection COVID-19 Ag Nasal Swab Sample 40 Tests TEST KIT, COVID-19 AG BINAX NOW PROFESSIONAL USE (40TEST/KT) BinaxNOW COVID-19 Ag Card is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations Product ships from Rally with minimum 30 days dating Testing 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 moderate, high or waived complexity tests; this 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 The BinaxNOW COVID-19 Ag Card is a lateral flow immunoassay for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from anterior nasal (nares) swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within seven days of the onset of symptoms Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status Positive results do not rule out bacterial infection or co-infection with other viruses Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed Negative 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 decisions The BinaxNOW COVID-19 Ag Card is intended for use by medical professionals or trained operators who are proficient in performing rapid lateral flow tests Sensitivity (PPA) 84.6% (entire population) Sensitivity (PPA) 95.6% (those with PCR cycle threshold [Ct] < 33) Specificity (NPA) 98.5% Onboard extraction allows the swab to be directly inserted into the test card Visually read results in 15 minutes - no instrument required The BinaxNOW COVID-19 Ag Card does not differentiate between SARSCoV and SARS-CoV-2 Manufacturer # 195000 Brand BinaxNOW™ Professional Use Manufacturer Abbott Rapid Dx North America LLC Country of Origin Unknown Application Rapid Test Kit Contents (40) Test Cards, 7.5 mL Extraction Reagent, (40) Sterile Nasal Swabs, Positive Control Swab, Negative Control Swab, Product Insert, Procedure Card Number of Tests 40 Tests Product Dating Acceptable Dating: we will ship >= 30 days Reading Type Visual Read Sample Type Nasal Swab Sample Test Format Card Format Test Method Lateral Flow Immunoassay Test Name COVID-19 Ag Test Type Antigen Detection Time to Results 15 Minute Results UNSPSC Code 41116144
More Information
- BinaxNOW COVID-19 Ag Card FDA EUA Letter
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