User manual4 Sep 2020 10:46
https://www.genedrive.com/documents/ID-COV2-IFU-07-U_DRAFT.pdf
The Genedrive 96 SARS-CoV-2 Kit Letter of Authorization, along with the authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Patients, and authorized labeling are available on the FDA website: https:// www.fda.gov/MedicalDevices/Safety/EmergencySituations/ ucm161496.htm. However, to assist clinical laboratories using the Genedrive 96 SARS-CoV-2 Kit, the relevant Conditions of Authorization are listed below.
• Authorized laboratories* using the Kit will include with result reports of the Genedrive 96 SARS-CoV-2 Kit all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media.
• Authorized laboratories using the Genedrive 96 SARS-CoV-2 Kit will perform the Genedrive 96 SARS-CoV-2 Kit as outlined in the Kit Instructions for Use. Deviations from the authorized procedures, including the authorized instruments, authorized extraction methods, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents, and authorized materials required to perform the Genedrive 96 SARS-CoV-2 Kit are not permitted.