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

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Risk analysis and control summary: The device master file should contain a summary of the ...

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

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

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BIOLOGICALS Biologicals are the medicinal, therapeutic/ diagnostic/ preventive preparatio...

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BIOLOGICALS Biologicals are the medicinal, therapeutic/ diagnostic/ preventive preparatio...

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BIOLOGICALS REGULATORY SERVICES Biologicals are the medicinal, therapeutic/ diagnostic/ pr...

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