FDA Final Rule
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From: | "Goodwin, Diana" <DGoodwin@CHSNJ.org> |
To: | "'Histonet'" <HistoNet@pathology.swmed.edu> |
Reply-To: | |
Date: | Wed, 22 Sep 1999 09:52:53 -0400 |
Content-Type: | text/plain |
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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