Matters of legal in nature including licensing, intellectual property, and lawsuits.
LGC is pleased to announce that the ACCURUN® Anti-SARS-CoV-2 Reference Material Kit is now CE marked for in vitro diagnostic use (CE-IVD). With this change in regulatory status, the new product name is ACCURUN Anti-SARS-CoV-2 Controls Kit. Bearing the CE mark and IVD symbol signifies that the ACCURUN Anti-SARS-CoV-2 Controls Kit meets extensive design control requirements. ACCURUN... Read more
LGC’s high-throughput (HTP) RT-PCR testing system for SARS-CoV-2 has been submitted to the FDA for Emergency Use Authorisation (EUA). Testing labs can now leverage LGC’s unrivalled expertise in automated sample preparation and high-throughput RT-PCR workflows in a ready-to-deploy solution. As the need for SARS-CoV-2 testing for both diagnostic and screening applications continues to grow, many organisations are... Read more
Nov 24, 2020 Fluidigm Assay is Among First Saliva-Based COVID-19 Tests Licensed for Use by Designated Labs in India SOUTH SAN FRANCISCO, Calif., Nov. 24, 2020 (GLOBE NEWSWIRE) — Fluidigm Corporation (Nasdaq:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced that the Central Drugs Standard Control Organisation (CDSCO) in India has licensed importation and... Read more
RELIABLE AND SENSITIVE VIRAL PURIFICATION USED FOR SARS-COV-2 VIRAL DETECTION AND ANALYSIS Zymo Research’s Quick-DNA/RNA Viral MagBead Kit has been cleared for in vitro diagnostic applications for use by EU member states. IRVINE, Calif., (Nov. 23, 2020) — Zymo Research announced today that its Quick-DNA/RNA Viral MagBead Kit was cleared for distribution to the European Union (EU) common market.... Read more
Germantown, Maryland, and Hilden, Germany, November 16, 2020 –QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the European launch of the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Test that will help healthcare professionals quickly identify and differentiate between patients with common seasonal respiratory infections and COVID-19. With the Northern Hemisphere in the grip of flu... Read more
CHELMSFORD, Mass., Nov. 16, 2020 /PRNewswire/ — Brooks Automation, Inc. (Nasdaq: BRKS) announced today that company management will participate in Stephens Annual Investment Conference 2020 on Thursday, November 19, 2020 which includes a 45-minute webcast beginning at 9:00 a.m. ET. The live webcast can be accessed through the Brooks investor relations website at www.brooks.investorroom.com/events. A replay... Read more
LOW COST, HIGH-SENSITIVITY DIAGNOSTIC TEST FOR COVID-19 DETECTION Zymo Research was recently granted the CE IVD certification for its Quick SARS-CoV-2 Multiplex Kit. IRVINE, Calif., (Nov. 10, 2020) — Zymo Research announced today that it obtained a CE IVD mark for the Quick SARS-CoV-2 Multiplex Kit in compliance with the Directive 98/79/EC of the European Parliament and of... Read more