Re: Immunohistochemistry CLIA regulations
|From:||"Peter A. Takes" <firstname.lastname@example.org>|
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 http://www.hcfa.gov, or check the
Federal Register at http://www.access.gpo.gov/su_docs/aces/aces140.html
for updated versions.
Hope this helps.
Peter A. Takes, Ph.D., RAC
Director, Clinical & Regulatory Affairs
Direct phone 1-314-615-6964
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