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Diagnostics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

Opti Medical Systems Gets CE Mark for Coronavirus Test Kit

The company said it has also received Emergency Use Authorization from the US Food and Drug Administration for its nucleic acid extraction kit.

Roche Garners FDA Emergency Use Authorization for Elecsys IL-6 Test in COVID-19 Patients

The test measures levels of interleukin 6, which is an indicator for acute inflammation and can be used to identify COVID-19 patients at high risk of intubation.

Eurofins Technologies Nabs CE Mark for Coronavirus Total Antibody Test

The company said its ELISA assay uses the SARS-CoV-2 nucleoprotein as an antigen for the early detection of antibodies against SARS-CoV-2.

FDA Issues Emergency Use Authorizations for Gravity Diagnostics, Aspirus, CSI Coronavirus Tests

The PCR-based tests, which detect regions in the virus' nucleocapsid gene, may only be performed at their developers' CLIA-certified labs.

MeMed Ramping Up Commercialization Efforts Following Regulatory Approvals

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The firm this week received the CE-IVD mark for its point-of-care infectious disease test and is in the middle of a US clinical study to support an FDA submission.

Jun 02, 2020

MeMed Receives CE-IVD Mark for Infectious Disease Test, POC Platform

Jun 02, 2020

Mobidiag Receives CE Mark for Two PCR SARS-CoV-2 Tests

Jun 01, 2020

At-Home Coronavirus Tests Get Nod From FDA But Agency Proceeding With Caution

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Jun 01, 2020

Siemens Healthineers Receives FDA Emergency Use Authorizations for Coronavirus Total Antibody Test

Jun 01, 2020

Healgen Gets FDA Emergency Use Authorization for Coronavirus Immunoassay

May 29, 2020

FDA Adds At-Home Self-Collection Template to SARS-CoV-2 Emergency Use Authorization Guidance

May 29, 2020

LetsGetChecked At-Home Molecular SARS-CoV-2 Test Nabs FDA Emergency Use Authorization

May 28, 2020

Quest Diagnostics Receives FDA Emergency Use Authorization for COVID-19 Self-Collection Test Kit

May 28, 2020

FDA Releases Reference Panel for Coronavirus Test Developers

May 27, 2020

Baebies Newborn Screening Assays for Galactosemia, Biotinidase Deficiency Get CE Mark

May 27, 2020

SpectronRx Coronavirus Test Gets FDA Emergency Use Authorization

May 26, 2020

GenScript Coronavirus Antibody Test Kit Gets CE-IVD Mark

May 26, 2020

Takeda's Alunbrig Gets First-Line FDA Approval With Abbott CDx in ALK-Positive Lung Cancer

May 26, 2020

Xiamen Wiz Biotech Rapid Coronavirus Immunoassay Kit Gets CE Mark

May 26, 2020

ArcDia Point-of-Care SARS-CoV-2 Antigen Test Receives CE Mark

May 26, 2020

Bio-Techne, Leica Biosystems Receive CE Mark for Pathology Detection Kit, Platform

May 26, 2020

Siemens Healthineers Receives CE Mark for Coronavirus Antibody Test

May 22, 2020

BioCore, SolGent, Seasun Get FDA Emergency Use Authorizations for Coronavirus Tests

May 22, 2020

P23 Labs Receives FDA Emergency Use Authorization for SARS-CoV-2 Test

May 22, 2020

Genedrive Receives CE Mark for SARS-CoV-2 PCR Kit