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What is an example of an over the counter medical device that produce (or has the...

What is an example of an over the counter medical device that produce (or has the potential to produce) pathology?

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A counter medical device that produce or has the potential to produce pathology .in vitro diagnostic medical device (IVD) if it is a reagent, calibrator, control material, kit, specimen receptacle, software, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic goods for in vitro use. It must be intended by the manufactured and can be used in vitro for the examination of specimens derived from the human body, principally for the purpose of giving information about a physiological or pathological state, a congenital abnormality or to determine safety and compatibility with a potential recipient, or to monitor therapeutic measures.

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