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caryS4

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caryS4

Re: StockDetective post# 89958

Thursday, 07/19/2018 2:51:12 AM

Thursday, July 19, 2018 2:51:12 AM

Post# of 205097
It's a complicated process to get FDA approval but Arrayit is progressing along really nicely. Here's more detail about the process:

https://www.marsdd.com/wp-content/uploads/2012/09/Pathway-to-Commercialization-for-an-In-Vitro-Diagnostic-in-the-US.pdf

I think Arrayit's test(s) are considered Class 1 (low risk) LDT (lab developed test) so approvals shouldn't take as long as the higher risk tests (Class 2 and 3).
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