FDA Final Rule

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From:"Goodwin, Diana" <DGoodwin@CHSNJ.org>
To:"'Histonet'" <HistoNet@pathology.swmed.edu>
Date:Wed, 22 Sep 1999 09:52:53 -0400

Good Morning , Histonet.

After reading Debbie Jennings-Sienna's article in the latest edition of
NSH in Action, I am still confused as to the classification of
commercially available primary antibodies.  Are they or are they not
considered to be ASR's?  Are we or are we not, as a clinical laboratory,
required to include a disclaimer on reports to clinicians of patients on
whom our lab has performed IHC testing using commercially available
primary antibodies?

Diana Goodwin,  HT
Trenton,  NJ

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