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Oncology Probes

Oncology Probes

Oncology Probes

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CE Marking & ISO certificatesAll probes from Kreatech are manufactured and marketed inaccordance with the European IVD Directive 98/79/EC. Apartfrom those products designed for research use (Kreatech´sASP, BSP, and mouse FISH probes, as well as the ULS Labelingproduct line), all Kreatech products are CE marked. In addition,Kreatech has obtained certificates for CE-marking of conformityfor our prenatal and PGD probes.All CE-marked FISH probes in this catalog are manufactured atKreatech Diagnostics facilities in Amsterdam, The Netherlands,and are labeled with ULS (Universal Linkage System).Manufacturing of all CE-marked products by Kreatech is carriedout according to international standards ISO 9001:2008 andISO 13485:2003 for which Kreatech holds certificates.Compliance to the European IVD Directive 98/79/EC, ISO9001:2008 and ISO 13485:2003 means that we are providinghigh quality in vitro diagnostic medical devices to be used fordiagnosis, prevention, monitoring, treatment, alleviation orinvestigation of disease, congenital disorders, physiologicaland/or pathological state of the human body without beingused in or on the human body.We strive to continuously improve the quality of these productsbased on the latest developments and techniques.CE marking & ISO Certificates115

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