SHOULD ANTIBODIES BE REGULATED BY THE FDA ?

Jose Perdomo biotech at slip.net
Sat Apr 8 03:13:22 EST 1995


G R Barclay <100066.300 at CompuServe.COM> wrote:
>
> Are these antibodies for clinical use? .... in which case they 
> will already be regulated -
> or are they for diagnostic use? .... where this can be an 
> opportunity for the user (operator) to pass liability back to the 
> manufacturer/supplier.
> 
> GRB


 -- 
> Dear GRB:

We are no talking of antibodies for therapeutic applications.
We are talking of the antibodies you find in Dako, Accurate Chemicals,
Sigma Chemical catalog.Furthermore, this regulation intends to 
classify labeled secondary antibodies, peroxidase avidin among other
similar reagents as Medical Devices.

Please, see posting by the Biodesign group in sci.bio newsgroup 
( I believe that it is also posted also in this Immunology section).

On that posting they included a good amount of background 
information on the subject. If you are interested in this issue,
please,review that information. After you do so, please give us
you opinion.

Best regards,

Jose Perdomo



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