FDA Manuals & User Guides

FDA ASSURE-100 Rapid COVID-19 Test Kit Instructions for Use ASSURE-100 Rapid COVID-19 Test Kit Oceanit Foundry LLC For use under an Emergency Use Authorization (EUA) only. For use with nasal…

CovAb SARS-CoV-2 Ab Test Kit

COVID-19 Self-Collected Antibody Test System Collection Kit Instructions for Use For prescription use only For use by individuals age 18 years or older or by adults collecting specimens from individuals…

FDA SynergyDx Home Collection Kit for COVID-19   Before you begin your collection: Please confirm FedEx is operating on a normal service schedule. Please confirm all kit components are included.…

FDA COVID-19 Test Home Collection Kit DTC Email: covid19@everlywell.com Libre nga Toll: +1 855-463-1670 CLIA-Certified Lab Partners FDA AUTHORIZED Physician-reviewed test results, fast and easy-to-read results, all from the comfort of…

FDA Mount Sinai SARS-CoV-2 Collection Kit Mga Instruksyon Mga Pasidaan ug Pag-amping Basaha ang tanang instruksyon sa dili ka pa magsugod sa pagkolekta sa espesimen sa laway. Kinahanglan nimong mailhan ang mga sample drop-off location and drop-off schedule from…

Contegra® Pulmonary Valved Conduit H020003 Presentation to the Pediatric Advisory Committee September 12, 2017 Dora Vega, MD, PhD Division of Epidemiology Office of Surveillance and Biometrics Center for Devices &…

P23 Labs TaqPath SARS-CoV-2 Assay Fact Sheet FACT SHEET FOR HEALTHCARE PROVIDERS P23 LABS, LLC P23 Labs TAQPATH SARS-COV-2 Assay October 20, 2020 Coronavirus Disease 2019 (COVID-19) This Fact Sheet…