I read "not for diagnostic use" in every protocol i saw. why is it so? which differences have the kits and material that are used for diagnostic purposes?


1 Answer 1


the FDA has to approve diagnostics - a rigorous and expensive process. Its a legal distinction, but also one which conveys a significant level of usefulness and reliability.

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    $\begingroup$ The quality controls (GMP, GLP and so on) which have to be implemented for diagnostic kits are also ways more complicated, what makes these kits more expensive. $\endgroup$
    – Chris
    Dec 19, 2013 at 15:43
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    $\begingroup$ Yes definitely - it takes years and $millions usually. and its effectiveness has to be clear and reproducible. $\endgroup$
    – shigeta
    Dec 19, 2013 at 18:01

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