Epstein-Barr virus
Abbott, QuidelOrtho, Werfen, Others Gain 510(k) Clearances in August
The US Food and Drug Administration granted marketing clearances for immunoassays for a variety of infectious diseases including syphilis, Lyme, and COVID-19.
Qiagen Obtains CE-IVD Mark on NeuMoDx Epstein-Barr Virus, Human Herpesvirus-6 Tests
The two new tests expand the CE-IVD menu on the NeuMoDx systems to 16 assays.
Roche Elecsys Epstein-Barr Virus Panel Nabs CE Mark
The panel, which includes three immunoassays, identifies the infection stage of the Epstein-Barr virus from a blood sample.
Roche Continues Expanding Diagnostic Portfolio for SARS-CoV-2 and Beyond
The company has plans to launch another SARS-CoV-2 antigen test, as well as an immunoassay to detect Epstein-Barr virus in the fourth quarter.
Roche BK Virus Test Garners FDA Clearance
The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA.