Respiratory Test Kit Healgen® COVID-19 / Flu A + B Antigen Combo Test 25 Tests

Features

• Healgen COVID-19 / Flu A&B Ag Combo Rapid Test Cassette (Swab ) is under an FDA EUA: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
• Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (swab) is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens
• Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (swab) is intended for use in individuals who are suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests
• Suitable for testing individuals 2+ years old - swabbing should be performed by an adult for children aged 2 to 13; user must be aged 14 + to perform self test
• Authorized Laboratories: 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 product 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
• Highly Sensitive: 92.0% sensitivity, 99.0% specificity for COVID-19
• Optimized Care: In just 15 minutes, test patients from a single swab sample and quickly determine the appropriate course for treatment during the same visit
• Efficient: Streamline workflow, testing for three pathogens with one simple procedure - saving your team critical time during the busy cold and flu season
• Easy & Convenient: Uses non-invasive anterior nasal swab samples and the kit includes all materials needed to run the test

More Information

• Healgen COVID-19 FLU A+B Ag Combo Cassette FDA EUA Letter
• Healgen COVID-19 FLU A+B Ag Combo Cassette Healthcare Providers Fact Sheet
• Healgen COVID-19 FLU A+B Ag Combo Cassette Patients Fact Sheet
• Healgen COVID-19 FLU A+B Ag Combo Cassette IFU
• Healgen COVID-19 FLU A+B Ag Combo Cassette Quick Ref
• SDS