Acon Laboratories L031-118B5-300 - Respira… | USA MedPremium
Respiratory Test Kit FlowFlex™ COVID-19 Antigen OTC 300 Tests per Case / 1 Test per Box CLIA Waived
USAMP#99501641SKU: L031-118B5-300FlowFlex™
Product Spotlight
Flowflex Covid-19 Antigen Home test is for use under an FDA EUA: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
Qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection
Product ships with minimum 60 days dating
This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years or older
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
Individuals who test positive should self-isolate and consult their healthcare provider as additional testing may be necessary and for public health reporting
Negative results are presumptive, and confirmation with a molecular assay, if necessary for patient management, may be performed
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
Clinical performance showed 93% sensitivity and 100% specificity
