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Nucleic acid based in vitro diagnostics for detection and identification of microbial pathogens в”Ђ general requirements, terms and definitions
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Protocol for evaluation of precision performance of the quantitative test in in-vitro diagnostic medical laboratory
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Protocol for evaluation of qualitative test performance in in-vitro diagnostic medical laboratory
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Protocol for interference testing in in-vitro diagnostic medical laboratory
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Protocol for evaluation of detection capability for measurement procedures in in-vitro diagnostic medical laboratory
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Protocol for measurement procedures comparison and bias estimation using patient samples in in-vitro diagnostic medical laboratory
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Protocol for analytical performance evaluation of infectious disease molecular diagnosis in in-vitro diagnostic medical laboratory
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In vitro diagnostic medical devices: Lateral flow immunoassay for infectious disease - General requirements for test performance
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In vitro diagnostic medical devices - Guideline for analytical performance evaluation for automated antinuclear antibody indirect immunofluorescence assay
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In vitro diagnostic medical devices - Guideline for analytical performance evaluation of automated blood grouping and antibody test system with dedicated anti-human globulin
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Manufacturers’ considerations for in vitro diagnostic medical devices in a public health crisis
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In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures
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In virto 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 test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
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Clinical laboratory testing and in vitro diagnostic test systems - Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
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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
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In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements
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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 (labelling) - Part 3: In vitro diagnostic instruments for professional use
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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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