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3. Definitions In these rules, unless the context otherwise requires, — (a) "academic clin...

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Definitions In these rules, unless the context otherwise requires, — (a) "academic clinica...

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3. Definitions In these rules, unless the context otherwise requires, — (a) "academic clin...

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9.0 Analytical performance characteristics: 9.1 Accuracy of measurement: This section shou...

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

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e) a description of the accessories, other medical device and other product that are not m...

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Definitions In these rules, unless the context otherwise requires, — (a) "academic clinica...

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Analytical performance characteristics: 9.1 Accuracy of measurement: This section should d...

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

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