herpes
Abbott, BioMérieux, Qiagen, Thermo Fisher Get 510(k) Clearances in May
The agency cleared new devices including syndromic panels for infectious diseases and digital pathology software as well updates to previously cleared tests.
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.
Abacus Diagnostica Gets CE Mark for Viral Meningitis, Encephalitis Test Kit
In addition to detecting the viruses that cause viral meningitis and encephalitis, the test kit can be used to identify herpes viruses.
Qiagen Obtains CE Mark for Molecular HSV Test on NeuMoDx Platforms
The assay is intended for the quantification and differentiation of herpes simplex virus 1 (HSV-1) and HSV-2 DNA, and runs on the NeuMoDx 96 and 288 systems.
FDA Clears DiaSorin Molecular VZV Test
The firm said that with this clearance it now provides a comprehensive menu of VZV and HSV tests from swab and cerebrospinal fluid specimens.
Apr 24, 2018
Feb 8, 2018
Vela Diagnostics HSV Test Gets FDA Clearance
Nov 29, 2016
FDA Clears Quidel's Solana Herpes, Varicella Test
Jul 31, 2014