South Korean FDA
Qlife, Precision Biosensor Announce South Korean Partnership
Under the agreement, Precision Biosensor will register Qlife's Egoo Health platform with the Korean Ministry of Food and Drug Safety.
A. Menarini Diagnostics SARS-CoV-2 Test Can Determine High, Low Viral Loads, Company Says
The Italian diagnostics firm believes its test can ID patients with high viral loads rapidly who need to be treated quickly.
Solgent Coronavirus Test Gets CE Mark, EUA from Korean, Philippines Authorities
The Korean company's test qualitatively detects the Orf1a and N genes of the novel coronavirus in specimens from patients with suspected respiratory infection.
Bioneer HIV-1 Dx Kit Gets Korea FDA Approval
The assay, which uses the Bioneer ExiStation molecular diagnostics instrument, was also recently registered for purchase by the Global Fund.
Genobio CTC Kit Cleared by Korean Regulators
The GenoCTC isolation kit isolates epithelial cell adhesion molecule-positive cells from liquid biopsies and was cleared as a reagent for an IVD device.
Oct 12, 2018
AmoyDx Lung Cancer CDx Approved in South Korea
Sep 26, 2017
Korean MFDS Clears Gencurix Lung Cancer Test
Jul 6, 2017