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Tag: SARS-CoV-2

Modularized synthetic biology enabled intelligent biosensors

Dai Y. Liu C.C. Recent advances on electrochemical biosensing strategies toward universal point-of-care systems.Angew. Chem. Int. Edit. 2019; 58: 12355-12368Krämer J. et al.Molecular probes,...

FDA Enforcement Policy for Face Masks and Barrier Face Coverings: Overview

The article provides an overview of the regulatory approach to be applied with respect to certain medical devices...

QuidelOrtho gets FDA authorisation for Sofia 2 antigen test

<!----> QuidelOrtho has received De Novo authorisation from the US Food and Drug Administration (FDA) for its Sofia...

Challenges in Assessing Long-Term Effects of Covid and Covid Vaccines,…

While information on the known risks is available in the Risk Management Plans (RMPs), missing information include the use in pregnancy,...

Wastewater-based monitoring is effective in detecting viral outbreaks in schools

Schools are among the most notable settings people associate with picking up viral infections such as the common cold, various types of the flu...

Innovative methodology to detect viral RNA

Experts from the University of Barcelona, the Institute for Advanced Chemistry of Catalonia (IQAC-CSIC), the Institute of Microelectronics of Barcelona (IMB-CNM-CSIC) and the Aragon...

Structure, folding and flexibility of co-transcriptional RNA origami

Jasinski, D., Haque, F., Binzel, D. W. & Guo, P. Advancement of the emerging field of RNA nanotechnology. ACS Nano 11, 1142–1164 (2017).Ohno, H.,...

US FDA grants EUA to the Mologic COVI-Go SARS-CoV-2 Ag Self-Test

<!----> The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to the Mologic COVI-Go...

MMA Guidance on Fees Related to Medical Devices: Overview

The document outlines the key points related to the Maltese regulatory requirements in the sphere of medical devices....

Spectrum Solutions’ saliva collection device gets 510(k) clearance in US

<!----> Spectrum Solutions has secured 510(k) Class II clearance from the US Food and Drug Administration (FDA) for...

Hologic secures approval for NovaSure V5 GEA device in Canada and Europe

<!----> Hologic has received approval for its NovaSure V5 global endometrial ablation (GEA) device to be used in...

Study validates Immunexpress’ SeptiCyte as Covid-19 triaging tool

<!----> Molecular diagnostic firm Immunexpress has announced that a new study has validated SeptiCyte RAPID as a triaging...

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