Respiratory Test Kit Genabio COVID-19 Rapid Self-Test 2 Tests per Kit

Genabio COVID-19 Rapid Self Test is for use under an FDA Emergency Use Authorization only: The Genabio COVID-19 Rapid Self-Test Kit is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from the SARS-CoV-2 virus This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older or adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older This test is authorized for individuals with symptoms 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 for 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 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 and the agent detected may not be the definitive cause of disease Individuals who test positive with the Genabio COVID-19 Rapid Self-Test Kit should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary All negative results are 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 measures such as isolating from others and wearing masks Negative results should be considered in the context of an individual's recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19 Product Specs Item Number 1271385 Catalog Number RA9-E00302 UOM CS Level 1 Family Description Lab-Waived Lab Level 2 Category Description Lab-Respiratory Testing Level 3 Group Description COVID Testing Level 4 Sub-Category Description COVID - Rapids Application Respiratory Test Kit Brand Genabio Buy American Act (BAA) Compliant No Contents 1 Each Kit Contains: (2) Covid-19 Test Cards, (2) Nasal Swabs, (2) Tubes, Quick Guide Instruction Country of Origin China FSA Eligible - Buy UOM Yes FSA Eligible - Primary UOM Yes FSA Eligible - Sell UOM Yes Manufacturer Genabio Diagnostics Inc Manufacturer # RA9-E00302 McKesson # 1271385 Number of Tests 2 Tests per Kit Purchase Program Type Standard Purchase Reading Type Visual Read Sample Type Anterior Nasal Swab Sample Specialty Immunoassay Test Format Cassette Format Test Kit Type Rapid Test Method Lateral Flow Test Name COVID-19 Rapid Self-Test Time to Results 15 Minute Results Trade Agreement Act (TAA) Compliant No UNSPSC Code 41116205