Nov 13, 2024 · In vitro diagnostics (IVD) are tests done on samples such as blood or tissue that have been taken from the human body. In vitro diagnostics can detect diseases or other conditions, and can be...

Dec 20, 2024 · An overview of how the FDA regulates in vitro diagnostic products (IVD). Manufacturers can find detailed information about complying with the Federal, Food, Drug and Cosmetic Act (FD&C Act).

Dec 20, 2022 · In vitro diagnostics (IVD) are tests or examinations conducted on samples retrieved from the human body such as blood or tissue samples. “In vitro”, meaning “in glass”, indicates that these tests are generally done using equipment like test tubes or petri dishes.

What is the IVDR? The In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR) is a new regulation that will create a robust, transparent, and sustainable regulatory framework that “improves clinical safety and creates fair market access for manufacturers and healthcare professionals” (1).

Oct 3, 2023 · IVD tests, approved by regulatory bodies and widely used, offer a safer and more reliable diagnostic option compared to LDTs. IVD tests undergo rigorous validation, ensuring effectiveness and accuracy, while LDTs offer individual control but lack regulatory approval.

Feb 10, 2020 · In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means ‘in glass’, meaning these tests are typically conducted in test tubes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself.

IVD Research is an ISO 13485 certified facility and an FDA Registered Manufacturer operating under cGMP’s. We are committed to complying with the latest regulatory requirements and maintaining our stringent Quality Management System.

Feb 4, 2025 · In this article, we explore the different types of IVDs, their clinical applications, and the advantages and limitations of each. Broadly, IVDs fall into two main categories: those conducted in clinical labs and those designed for point-of-care settings.

Sep 13, 2024 · A comprehensive guide to in vitro diagnostic (IVD) devices, explaining the design, development, and manufacture of these products, applicable regulations, and how they differ from traditional medical devices.

Oct 31, 2024 · IVDs analyze biological samples - such as blood, urine, and tissues - to detect markers that indicate specific health conditions. By studying these, clinicians can gain insights into various diseases, including infections, genetic disorders, metabolic abnormalities, and cancers.