Respiratory Test Kit GenBody COVID-19 Ag 25 Tests CLIA Waived

Features

• The GenBody COVID-19 Ag Test if for use under an FDA Emergency Use Authorization: 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
• Ships with minimum 30 Days Dating
• The GenBody COVID-19 Ag is an immunochromatographic rapid diagnostic test (RDT) intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in Anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests
• 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
• 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
• Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
• Negative results should be treated as presumptive and may be confirmed with a molecular assay, if necessary, for patient management
• 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
• Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19
• The GenBody COVID-19 Ag is intended for use by medical professionals or operators trained in performing tests in point of care settings
• GenBody COVID-19 Ag test allows for near patient testing without the need for instrumentation or special equipment

More Information

• GenBody COVID-19 Ag Rapid Test Kit FDA EUA Letter
• GenBody COVID-19 Ag Rapid Test IFU
• GenBody COVID-19 Ag Rapid Test Quick Reference
• GenBody COVID-19 Ag Rapid Test Brochure
• GenBody COVID-19 Ag Rapid Test Healthcare Providers Fact Sheet
• GenBody COVID-19 Ag Rapid Test Patients Fact Sheet
• GenBody COVID-19 Ag Shelf Life Extension Letter July 2022