Nano-Ditech Corporation #ND-MD8152 Nano-CheckTM RSV Test (25/KT) FDA 510(k) Cleared/CLIA waived (k240280, CW240005) For in vitro diagnostic use For prescription use only Infant/Child: 6 months – 6 years old Adult Senior: ≥ 60 years old Anterior Nasal Swab Rapid results in 15 minutes For In Vitro diagnostic use • For Prescription Use • For Use with Kit Provided Swabs • CLIA Complexity-WAIVED for use with anterior nasal swab • Certificate of Waiver is required to perform the test in a waived setting • Laboratories with a Certificate of Waiver must follow the manufacturer's instructions for performing the test The Nano-Check™ RSV Test is a rapid immunochromatographic assay for the qualitative detection of respiratory syncytial virus (RSV) nucleoprotein antigen in anterior nasal swab specimens from patients with signs and symptoms of respiratory infections. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients aged 6 months to 6 years old, and adults over 60 years of age. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by viral cell culture or an alternative method, such as an FDA-cleared molecular assay.
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