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17.0 In use stability: This section should provide information on in use stability studies...

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9.2 Reproducibility: This section should include reproducibility estimates and information...

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

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Conditions for registration of medical device testing laboratory The following conditions ...

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Conditions for registration of medical device testing laboratory The following conditions ...

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In use stability: This section should provide information on in use stability studies for ...

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Reproducibility: This section should include reproducibility estimates and information abo...

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

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Conditions for registration of medical device testing laboratory The following conditions ...

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