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in vitro diagnostics - antibodies

Jack H. Pincus jhpincus at cris.com
Fri May 12 17:54:59 EST 1995


In article <3otk1j$ma8 at news1.best.com>, biotech at 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 at cris.com




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