Re: Immunohistochemistry CLIA regulations

From:"Peter A. Takes" <>

Patsy, et al.:

Diane is right.  CLIA does (or did) indeed have a regulation pertaining
to IHC.  It is "In-house developed procedures for immunohistochemistry
tests".  The version I have was issued June 29, 1994; I wouldn't be
surprised if there have been updates, especially in the light of FDA
actions over the past few years.  Unfortunately, I have not kept up with
this particular section.

A few routes to go: check HCFA at, or check the
Federal Register at
for updated versions.

Hope this helps.


Peter A. Takes, Ph.D., RAC
Director, Clinical & Regulatory Affairs
Direct phone 1-314-615-6964
FAX 1-314-615-6912
Pager 1-314-841-9351

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