New: CE marked MACS® IVD Antibodies
Product News Sep 16, 2016
Miltenyi Biotec has expanded its assortment of antibodies with a series of CE marked in vitro-diagnostic medical devices – MACS® IVD Antibodies. They can be used in both clinical flow cytometry and in the quality control of cellular products for translational research. The renowned biotech company from Bergisch Gladbach offers a comprehensive range of MACS® GMP (good manufacturing practice) and RUO (research use only) products, which contains, amongst other things, more than 9,000 RUO MACS Antibodies for flow cytometry.
Now Miltenyi Biotec has added an assortment of CE marked MACS IVD (in vitro diagnostic) antibodies to its portfolio and thereby offers the appropriate solution for clinical flow cytometry. CE marked IVD products meet the requirements of the European directive 98/79/EC for in-vitro diagnostics (IVDD). They are manufactured and controlled under the ISO 13485 certified quality system.
Highest standards of quality
In translational research, just as in clinical flow cytometry, a high level of standardization with the best possible quality is of the utmost importance. With the use of MACS® IVD products this is guaranteed, thereby fulfilling regulatory demands while also simplifying the establishment of internal validation processes at the same time.
The production of MACS IVD products is characterized by distinguishing features that include validated process controls and comprehensive documentation, whereby reproducible results can be ensured. An independent QC department carries out quality control measures of the highest standards at Miltenyi Biotec’s production location in Germany.