[Histonet] FDA approved IVD antibody

[Vickroy, Jim]

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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