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WELLlife™
WELLlife COVID-19 Antigen Test Rx with Control Kit; 25 Tests, 1 Positive Control Swab and 1 Negative Control Swab per Kitbox
Details
Device typeSARS-CoV-2 antigen IVD, kit, rapid ICT, clinical: A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease (COVID-19), in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
FDA categorySimple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Device ID00816862028577
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information