Registration number (WIID)Project No.TitleStatus
5098EN 375:2001Information supplied by the manufacturer with in vitro diagnostic reagents for professional useAtcelts
24023EN ISO 15197:2003/AC:2005In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2003)Atcelts
62239CEN/TS 17305:2019Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNAAtcelts
65452CEN/TS 17390-2:2020Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood - Part 2: Isolated DNAAtcelts
25659EN ISO 15189:2007Medical laboratories - Particular requirements for quality and competence (ISO 15189:2007)Atcelts
5102EN 14820:2004Single-use containers for human venous blood specimen collectionAtcelts
27616EN ISO 18113-1:2009In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/FDIS 18113-1:2009)Atcelts
37592EN ISO 18113-4:2011In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)Atcelts
37591EN ISO 18113-3:2011In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)Atcelts
41040CEN/TS 16835-3:2015Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasmaAtcelts
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