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Diagnostics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

Abbott POC Coronavirus Test Snares FDA Emergency Use Authorization

The ID Now COVID-19 test is the second assay from the company to receive EUA from the FDA, following the same designation issued to the Abbott RealTime SARS CoV-2.

Luminex Receives FDA Emergency Use Authorization for Coronavirus Multiplex Panel

The NxTag CoV Extended Panel is a multiplex PCR test that uses the company's bead-based NxTag technology to detect coronavirus in nasopharyngeal swab specimens.

Sysmex Obtains Japan Marketing Approval to Distribute BGI Genomics Coronavirus Kit

Sysmex anticipates delivering the kit to Japanese medical institutions this month for diagnosis of the SARS-CoV-2 infection.

Avellino Labs Receives FDA Emergency Use Authorization for Coronavirus Test

The AvellinoCoV2 real-time PCR test is designed for the detection of nucleic acid from SARS-CoV-2 from nasopharyngeal and oropharyngeal swab specimens.

PerkinElmer's Euroimmun ELISA Coronavirus Tests Get CE Mark

The anti-SARS-CoV-2 antibodies for classes IgA and IgG are two of the first antibody detection tests to receive CE making and be made available for SARS-CoV-2 testing.

Mar 26, 2020

SARS-CoV-2 Serology Testing Ramping Up to Address Next Stages of Pandemic

Mar 26, 2020

Fosun Long March Gets Chinese Regulatory Approval for Coronavirus MDx Kit

Mar 26, 2020

Thermo Fisher Scientific COVID-19 Test Receives CE Mark, Expanded FDA EUA

Mar 25, 2020

Quidel SARS-CoV-2 Test Receives Expanded FDA Emergency Use Authorization

Mar 24, 2020

PerkinElmer Coronavirus Assay Gets FDA Emergency Use Authorization

Mar 24, 2020

BioMérieux Rapid Coronavirus Test Gets FDA Emergency Use Authorization

Mar 24, 2020

Mesa Biotech COVID-19 Test Receives FDA Emergency Use Authorization

Mar 24, 2020

GenoScreen Gets CE-IVD Mark for Tuberculosis Test

Mar 23, 2020

Citing Coronavirus Pandemic, MedTech Europe Seeks Delay in New European IVD Regulations

Mar 23, 2020

AusDiagnostics Gets CE Mark for Multiplex Coronavirus, Flu, RSV Assay

Mar 23, 2020

Novacyt Primerdesign Coronavirus Dx Test Receives FDA Emergency Use Authorization

Mar 22, 2020

FDA Warns Consumers About Fraudulent At-Home COVID-19 Test Kits

Mar 21, 2020

Cepheid Coronavirus Assay First Point-of-Care Test to Get FDA Emergency Use Authorization

Mar 20, 2020

Bioneer Receives CE Mark for Coronavirus Kits, Inks Supply Agreement With Romania

Mar 20, 2020

Coronavirus Test From DiaSorin Molecular Gets FDA Emergency Use Authorization

Mar 19, 2020

FDA Issues Emergency Use Authorization for GenMark Coronavirus Assay

Mar 19, 2020

Todos Medical Inks Agreement to Distribute Coronavirus POC Test in US, Israel

Mar 18, 2020

Abbott Garners Emergency Use Authorization for SARS-CoV-2 Test

Mar 18, 2020

Qiagen Respiratory Panel With Coronavirus Targets Receives CE Mark

Mar 18, 2020

Sen. Rand Paul Introduces Bill to Keep Lab Test Regulation out of FDA's Grasp