Question -   I am trying to figure why we should switch to an FDA approved IVD 
antibody  for Cd117 from the current IVD antibody we use that is not FDA 
approved.   Most of the IHC antibodies we use are not FDA approved.   I am 
fully aware of the extra things we have to do if an antibody is a RUO or ASR 
antibody but am a little questioned about the true advantage of the FDA 
approval.

The cost of course for an FDA approved antibody is extremely high in comparison 
to  other IVD antibodies that are not FDA approved. (as much as five times as 
much).   In this case I am trying to figure out what is so special about Cd117.

If someone could enlighten me I would be grateful.

Jim



James Vickroy BS, HT(ASCP)

Surgical  and Autopsy Pathology Technical Supervisor
Memorial Medical Center
217-788-4046


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