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(b) the intended user (lay person or professional); (c) a general description of the princ...

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Description and specification, including variants and accessories of the in vitro diagnost...

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PARAMETERS FOR CLASSIFICATION FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES 1. Basic principles ...

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The device master file should include the following device descriptive information:— (a) i...

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PARAMETERS FOR CLASSIFICATION FOR IN VITRO DIAGNOSTIC MEDICAL DEVICES 1. Basic principles ...

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Metrological traceability of calibrator and control material values Where applicable, summ...

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