Why test for interference by biotin of your assay?
The FDA warns that biotin may interfere with lab tests.
Biotin is a vitamin that can be found in (multi-vitamin) pills or supplements for hair, skin, and nail growth. More and more people take or consider taking these pills or supplements. However, this biotin can significantly interfere with certain laboratory test and may cause test results that are incorrect.
Are you familiar with accuspheres?
Accuspheres are formed by combining a suitable matrix with the component of interest. This solution (minimal of 50 μl) is dripped into liquid nitrogen followed by a freeze-drying process, which forms the stable sphere.
We wish our customers, colleagues, partners and other stakeholders the best of joy and cheer for Christmas and the coming year.
ISO 13485:2016 certification
We are proud to announce that Future Diagnostics Solutions has now succesfully transitioned its Quality Management System to ISO 13485:2016. The scope of the approval is applicable to research, development, manufacturing, sales and distribution of in vitro diagnostic medical devices and accessories, including R&D services and contract manufacturing. Future Diagnostics is ISO 13485 certified since 2004.
IVDR & Immunoassays Mini-Symposium
Surely you have heard about it: the IVD, the new In Vitro Diagnostic Medical Devices Regulation. Published in May 2017, it replaces the In Vitro Diagnostic Medical Devices Directive (IVDD) and brings new requirements for manufacturers. The good news is: there is a five-year transition period. But do you know how this affects you, and how you will make sure you are fully compliant by 2022?
At MEDICA we organized the first IVDR & Immunoassays Mini-Symposium together with Qarad and Tüv Süd.
BIOCDx EU Project
Future Diagnostics is proud to be part of the BIOCDx EU Project