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BS PD CEN/TS 17390-2:2020

Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood-Isolated DNA

BSI Group, 01/24/2020

Publisher: BS

File Format: PDF

$125.00$251.46


Published:24/01/2020

Pages:30

File Size:1 file , 810 KB

Note:This product is unavailable in Ukraine, Russia, Belarus

This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for the examination of human DNA isolated from circulating tumour cells (CTCs) during the pre-examination phase before a molecular examination is performed.

This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities.

Cross References:
EN ISO 15189:2012
ISO 15189:2012
ISO 15190
EN ISO/IEC 17020 (ISO/IEC 17020:2012) AS
ISO/IEC 17020:2012


All current amendments available at time of purchase are included with the purchase of this document.

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