IVD

Illustration of a sticky note pinned to a blue background with the words, December 4, written on it.

FDA Proposed Rule on LDT Regulation: Comments Due Soon

Shannon Bennett, MS, MBA

Clinical laboratories should strongly consider submitting comments before the Dec. 4 deadline

Rows of small glass vials with a pipette tip dripping clear liquid in the center vial against a purple and blue lit background.

Empower Your Clinical Lab With Chemiluminescence Immunoassays

Fapon Biotech Inc.

Automated chemiluminescence immunoassays facilitate rapid and accurate detection of target analytes in patient samples, enabling rapid diagnosis and treatment

Map of the The IVDR applies to the 27 countries of the European Union, as well as the four countries of the European Free Trade Association States.

What is IVDR? How Can You Ensure Your Lab Complies with It?

Glenn S. Demby

Tips to help your clinical lab meet the EU In Vitro Diagnostic Regulation (IVDR)

Man in white jumpsuit wearing goggles and black lanyard reads laptop while crossing an engineering lab floor

The Impact of New Regulations on IVD Manufacturing

Learn how the new IVDR (in vitro diagnostic regulation) rules affect future innovations

Photograph of two clinical lab personnel discussing and monitoring the flow cytometry workflow on their handheld tablet device.

How Can the Latest PCR Systems Improve Your Clinical Lab?

Thermo Fisher Scientific

QuantStudio™ PCR systems meet IVDR requirements, create digital ecosystems, and help reduce the carbon footprint

Illustration of a clinical lab professional in a lab developing a Lab Developed Test.

Current Challenges Facing Lab Developed Tests

Pallavi Upadhyay, PhD

Though challenging, creating lab developed tests is crucial for molecular diagnostics labs

Illustration of different in vitro diagnostics in a clinical lab.

The IVDR Deadline: How Will It Impact the Diagnostics Industry?

Manoj Gandhi, MD, PhD

On May 26, the 1998 IVDD becomes obsolete after a five-year transition to the EU’s IVDR process

MDCG guidance documents help interpret classification rules for EU MDR and IVDR

How to Classify Medical and Diagnostic Devices for European Markets

Raeesa Gupte, PhD

MDCG guidance documents help interpret classification rules for EU MDR and IVDR

Benefits of Liquid Stable Clinical Reference Materials for Clinical Laboratories

A liquid stable design improves laboratory efficiencies and productivity