marketing clearance
FDA Grants Marketing Authorization for Invitae Hereditary Cancer DNA Sequencing Test
The Invitae Common Hereditary Cancers Panel is the first test of its kind to obtain FDA marketing authorization, creating an easier pathway for similar tests.
PerkinElmer's Euroimmun Gets CE Mark SARS-CoV-2 Antibody Test
The test leverages ELISA technology and uses non-pathogenic viral proteins, enabling its use in common lab settings either manually or automatically.
Sysmex Gets Japanese Approval for Coronavirus Antigen Test
The chemiluminescence enzyme immunoassay is designed to detect SARS-CoV-2 antigens in nasopharyngeal and nasal swab samples.
Theradiag Kits for Biotherapy Monitoring Get CE Marks
The four kits are compatible with the i-Track automated analyzer for biotherapy monitoring, which received CE marking in late 2019.
Singapore Clears New SARS-CoV-2 Assay for Clinical Use
A*STAR and Tan Tock Seng Hospital developed the test, which is the first diagnostic to be deployed in the country's hospitals since the outbreak began in December.
Jan 8, 2019
Grifols Blood Typing Solution Approved by FDA
Dec 6, 2017
FDA Clears DxNA's Valley Fever Molecular Test
Sep 26, 2017