Re: IHC non-FDA Approved Tests

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From:Peter Takes <> (by way of histonet)
To:histonet <>
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One additional note - a couple of articles I was involved with that may be
of some help in explaining the issues -  Clinical Laboratory News 24(4):10
[1998]; Clinical Laboratory News 21(7):43-44 [1995].


Peter A. Takes, Ph.D., RAC
Director, Clinical & Regulatory Affairs
Stereotaxis, Inc.
Ph. 1-314-615-6964; Pager: 841-9351

> From: Laura Bliven <>
> To:
> Subject: IHC non-FDA Approved Tests
> Date: Wednesday, September 30, 1998 3:36 PM
> Is anyone adding disclaimers to surgical reports pertaining to IHC
results, and if so how are they worded?
> Also, does anyone have information on the legal issues and implications
relating to non-FDA approved IHC reporting and testing.  Is there a web
site one can access for this information?  I have to participate in another
meeting about this and would like to make it sweet and short.
> Thanks in advance.
> Laura

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