Genbody America, LLC

Genbody America, LLC manufactures and distributes the GenBody COVID-19 Ag rapid antigen test, an FDA Emergency Use Authorization (EUA) authorized point-of-care diagnostic device. The test uses anterior nasal swab specimen collection for user comfort and demonstrates 92.31% sensitivity and 99.04% specificity in detecting acute SARS-CoV-2 infection. The company was selected by the National Institutes of Health (NIH) for the Rapid Acceleration of Diagnostics (RAD) program to support U.S. production of the COVID-19 Ag test. GenBody America offers the test in multiple packaging configurations—individual kit boxes (25 tests per kit), carton boxes (36 kits per carton), and pallet quantities (12 cartons per pallet)—suitable for distributors, CLIA-certified testing sites, and clinical laboratories. Each test kit includes single-use test devices individually foil-pouched, sterilized anterior nasal swabs, single-use extraction tubes with dropper tips, extraction solution, and positive and negative external controls. The company maintains large manufacturing capacity and immediate availability for distribution through major medical distributors including Henry Schein, Premier, and others. GenBody America operates as a B2B supplier focused on high-volume diagnostic test distribution.