Search the Community
Showing results for tags 'ifu'.
Found 2 results
-
So, my manager (I'm the asst. mgr) has me looking at ALL our reagent IFU's to make sure that our SOP's are in line with the IFU's since this new FDA thing is coming up stating that anything used outside of the IFU is an LDT.....(or something to that effect). We are a large academic medical center and do 95+% of our own abid's. As I'm reading these IFU's for screen and panel cells they are all saying "Do not use beyond expiration". We often use expired panel cells to help R/in or R/out antibodies - does this new ruling mean that we can no longer do that....? Even if we run +/- controls? I'm stressing just a little! We also freeze some of the more "rare" antiseras - but we don't "report" those reactions or interpretations............so, basically that's just for "information" -
