Respiratory Health Control Set
COVID-19 / Influenza A + B Positive Level / Negative Level
4 Swabs
Visby Medical PS-400381

Respiratory Health Control Set
COVID-19 / Influenza A + B Positive Level / Negative Level
4 Swabs
Visby Medical PS-400381

Features For use under emergency use authorization (EUA) only: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2 The Respiratory Health Control Swabs (inactivated) consists of 2 individually packaged positive control swabs and 2 individually packaged negative control swabs The Respiratory Health Control Swabs (inactivated) are intended for use as an external positive and negative quality control to monitor the performance of the Visby Medical Respiratory Health Test The viral particles have been inactivated using irradiation and chemical treatments, and the human cells have been inactivated using thermal treatment

Manufacturer # PS-400381 Brand Visby Medical™ Manufacturer Visby Medical Country of Origin United States Application Control Set Container Type Pouch For Use With For Visby Medical Respiratory Health Test Form Swab Levels Positive Level / Negative Level Test Category Respiratory Test Name COVID-19 / Influenza A + B Test Type Respiratory Health UNSPSC Code 41116145 Volume 4 Swabs