CE marked MACS® IVD Antibodies by Miltenyi Biotec – Compliant with IVDD and produced according to ISO 13485

BERGISCH GLADBACH, 19. September 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.
BERGISCH GLADBACH, 19. September 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. 

MACS® IVD-Antibodies 
For further information see 
www.miltenyibiotec.com/clinicalflowcytometry 

Meet us at one of the following events: 
11.-14. September 2016 European Society for Clinical Cell Analysis (ESCCA) annual conference, Edinburgh, Schottland 
27.-30. September 2016 45. Jahrestagung der Deutschen Gesellschaft für Immunologie (DGfI), Hamburg 


About Miltenyi Biotec
Miltenyi Biotec is a global provider of products and services that advance biomedical research and cellular therapy. The company’s innovative tools support research at every level, from basic research to translational research to clinical application. This integrated portfolio enables scientists and clinicians to obtain, analyze, and utilize the cell. Miltenyi Biotec’s technologies cover techniques of sample preparation, cell isolation, cell sorting, flow cytometry, cell culture, molecular analysis, and preclinical imaging. Their more than 25 years of expertise spans research areas including immunology, stem cell biology, neuroscience, and cancer, and clinical research areas like hematology, graft engineering, and apheresis. In their commitment to the scientific community, Miltenyi Biotec also offers comprehensive scientific support, consultation, and expert training. Today, Miltenyi Biotec has more than 1,700 employees in 25 countries – all dedicated to helping researchers and clinicians around the world make a greater impact on science and health.


Miltenyi Biotec Media Contact 

Holger Buelow
+49 2204 8306-6680
press@miltenyibiotec.de