Diagnostics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

Scopio Labs Receives FDA 510(k) Clearance for Automated Hematology Platform

The product, which received the CE mark earlier this year, uses digital imaging and AI to automate peripheral blood smear analysis.

LumiraDx Gets FDA Emergency Use Authorization for PCR-Based Coronavirus Test

The assay does not require nucleic acid extraction or purification, unlike a LumiraDx SARS-CoV-2 test that received Emergency Use Authorization in August.

Coronavirus Testing Specimen Collection Devices From DNA Genotek, Clinical Enterprises Get FDA EUAs

DNA Genotek's devices are used with SARS-CoV-2 tests from Clinical Reference Laboratory and P23 Labs, while Clinical Enterprises' kit is offered by Eurofins.

Siemens Healthineers Receives CE Mark for Rapid Antigen Test to Detect SARS-CoV-2

The company said its rapid antigen test provides results in 15 minutes and is easy to administer for healthcare professionals using a nasopharyngeal swab.

FDA Relaxes Rules for Flu, RSV Molecular Tests During Coronavirus Health Emergency

The new guidance allows developers to use other transport media and sample types without first obtaining 510(k) clearance.

Oct 12, 2020

Abbott SARS-CoV-2 Antibody Test Receives FDA Emergency Use Authorization

Oct 12, 2020

Thermo Fisher Gets CE Mark for Coronavirus Antibody Tests

Oct 12, 2020

Spectrum Solutions Saliva Collection Device, Access Bio, Genalyte Coronavirus Tests Get FDA EUAs

Oct 12, 2020

FDA Decision to Halt EUA Review of LDTs Raises Reimbursement, Liability Questions for Labs

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Oct 09, 2020

Beckman Coulter Gets Emergency Use Authorization from FDA for Second Coronavirus Antibody Test

Oct 08, 2020

FDA Grants Emergency Use Authorizations for Seasun Biomaterials, Zeus Scientific Coronavirus Tests

Oct 07, 2020

FDA Will No Longer Review EUA Submissions for SARS-CoV-2 Lab-Developed Tests

Oct 07, 2020

FDA Issues Emergency Use Authorization for UCLA NGS-Based SARS-CoV-2 Test

Oct 06, 2020

BioFire Diagnostics, UMass Medical Coronavirus Tests Get FDA Emergency Use Authorization

Oct 06, 2020

Thermo Fisher Scientific Gets FDA Emergency Use Authorization for Coronavirus Total Antibody Test

Oct 05, 2020

Becton Dickinson Gets FDA 510(k) Clearance for Fully Automated Flow Cytometry Solution

Oct 03, 2020

Quidel Rapid Antigen POC Test for SARS-CoV-2, Influenza A/B Receives FDA Emergency Use Authorization

Oct 02, 2020

Chembio Diagnostics HIV-Syphilis Testing System Receives FDA Approval

Oct 02, 2020

LabCorp Receives FDA Emergency Use Authorization for SARS-CoV-2 RNA Extraction Method

Oct 02, 2020

Tempus, Alimetrix Molecular Coronavirus Tests Get FDA Emergency Use Authorization

Oct 01, 2020

DiaSorin Gets FDA Approval for Six Hepatitis B Serology Tests

Oct 01, 2020

Centogene, Aeon Global, Akron Children's, National Jewish Health Coronavirus Tests Get FDA EUAs

Oct 01, 2020

FDA Grants Emergency Use Authorizations to DiaSorin, NanoEntek, Nirmidas Coronavirus Antibody Tests

Sep 30, 2020

BioGX BV Gets CE-IVD Mark for Coronavirus, Flu, RSV Combo Test

Sep 30, 2020

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Diagnostics Regulatory News & FDA Approvals

Scopio Labs Receives FDA 510(k) Clearance for Automated Hematology Platform

LumiraDx Gets FDA Emergency Use Authorization for PCR-Based Coronavirus Test

Coronavirus Testing Specimen Collection Devices From DNA Genotek, Clinical Enterprises Get FDA EUAs

Siemens Healthineers Receives CE Mark for Rapid Antigen Test to Detect SARS-CoV-2

FDA Relaxes Rules for Flu, RSV Molecular Tests During Coronavirus Health Emergency

Abbott SARS-CoV-2 Antibody Test Receives FDA Emergency Use Authorization

Thermo Fisher Gets CE Mark for Coronavirus Antibody Tests

Spectrum Solutions Saliva Collection Device, Access Bio, Genalyte Coronavirus Tests Get FDA EUAs

FDA Decision to Halt EUA Review of LDTs Raises Reimbursement, Liability Questions for Labs

Beckman Coulter Gets Emergency Use Authorization from FDA for Second Coronavirus Antibody Test

FDA Grants Emergency Use Authorizations for Seasun Biomaterials, Zeus Scientific Coronavirus Tests

FDA Will No Longer Review EUA Submissions for SARS-CoV-2 Lab-Developed Tests

FDA Issues Emergency Use Authorization for UCLA NGS-Based SARS-CoV-2 Test

BioFire Diagnostics, UMass Medical Coronavirus Tests Get FDA Emergency Use Authorization

Thermo Fisher Scientific Gets FDA Emergency Use Authorization for Coronavirus Total Antibody Test

Becton Dickinson Gets FDA 510(k) Clearance for Fully Automated Flow Cytometry Solution

Quidel Rapid Antigen POC Test for SARS-CoV-2, Influenza A/B Receives FDA Emergency Use Authorization

Chembio Diagnostics HIV-Syphilis Testing System Receives FDA Approval

LabCorp Receives FDA Emergency Use Authorization for SARS-CoV-2 RNA Extraction Method

Tempus, Alimetrix Molecular Coronavirus Tests Get FDA Emergency Use Authorization

DiaSorin Gets FDA Approval for Six Hepatitis B Serology Tests

Centogene, Aeon Global, Akron Children's, National Jewish Health Coronavirus Tests Get FDA EUAs

FDA Grants Emergency Use Authorizations to DiaSorin, NanoEntek, Nirmidas Coronavirus Antibody Tests

BioGX BV Gets CE-IVD Mark for Coronavirus, Flu, RSV Combo Test

PerkinElmer Newborn Screening Assay Receives CE-IVD Mark

Breaking News

BD, CerTest Biotec Get CE-IVD Mark for Combination COVID-19, Influenza, RSV Test on BD Max

Thermo Fisher Scientific Q3 Revenues Soar 36 Percent

Scopio Labs Receives FDA 510(k) Clearance for Automated Hematology Platform

MDxHealth Q3 2020 Revenues Drop 6 Percent

Abbott Q3 Diagnostics Revenues Increase 38 Percent

Calibre Scientific Acquires Blood Grouping Reagent Manufacturer Lorne Laboratories

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Scopio Labs Receives FDA 510(k) Clearance for Automated Hematology Platform

Coronavirus Testing Specimen Collection Devices From DNA Genotek, Clinical Enterprises Get FDA EUAs

LumiraDx Gets FDA Emergency Use Authorization for PCR-Based Coronavirus Test