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?
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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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2$\begingroup$ 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 '13 at 15:43
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1$\begingroup$ Yes definitely - it takes years and $millions usually. and its effectiveness has to be clear and reproducible. $\endgroup$ – shigeta Dec 19 '13 at 18:01
