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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
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In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) Part 2: In vitro diagnostic reagents for professional use
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In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
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In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of assigned values for catalytic concentration of enzymes assigned to calibrators and control materials
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In vitro diagnostic medical devices — Measurement of quantities in samples of biological origin — Requirements for certified reference materials and the content of supporting documentation
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In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation
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In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples, 2nd Edition
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In vitro diagnostic systems — Measurement of quantities in samples of biological origin — Requirements for content and presentation of reference measurement procedures
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In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens - Laboratory quality practice guide
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