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
