[Histonet] Tests not FDA -approved / cleared

[shehnaz khan]

Hi netters,

Wondering what's been done for the following CAP standard (COM
40200): Tests not FDA -approved / cleared. "The lab has a list of tests not
approved /cleared by FDA that have been implemented during the previous two
years".

Does this apply to special stains too?

Is this applicable for IHC done manually using Dako antibodies?

Thanks in advance.

S Kahn

Chief scientist