From owner-diagnostics@net.bio.net Thu May 11 23:00:00 1995
Path: biosci!bcm!cs.utexas.edu!news.sprintlink.net!warp.cris.com!usenet
From: jhpincus@cris.com (Jack H. Pincus)
Newsgroups: bionet.diagnostics
Subject: Re: in vitro diagnostics - antibodies
Date: 12 May 1995 22:54:59 GMT
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In article <3otk1j$ma8@news1.best.com>, biotech@best.com says...
>
>What is the regulatory status of using antibodies for clinical, in
>vitro diagnostics?  I have heard rumors that the congress is about to
>change the regulations

I don't think it is Congress who is chaning the regulations.  The FDA has 
proposed classifying certain antibodies used for histochemistry and 
cytochemistry as Class II medical devices.  I don't know the details but 
some people feel that it could affect the development amd use of these 
antibodies.

Jack H. Pincus
jhpincus@cris.com


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