RapCov Documents
Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for emergency use of RapCov™ Rapid COVID-19 Test (EUA # 202686, approval issued on 1/11/2021).The RapCov™ Rapid COVID-19 Test is authorized to be accompanied with labeling entitled “RapCov™ Rapid COVID-19 Test” Instructions for Use, the quick reference guide “Quick Reference Instructions for RapCov™ Rapid COVID-19 Test,” and the following product-specific information pertaining to the emergency use, which is required to be made available to healthcare providers and recipients.
Expiration Date Extension of EUA202686
EUA202686 Advaite Letter of Authorization 01-11-2021
Advaite Letter Granting EUA Revision
RapCov™ Rapid COVID-19 Test – Instructions for Use
