RE: FDA Final Rule
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From: | "Jennings-Siena, Debbie" <ds.jennings-siena@baylordallas.edu> |
To: | "'Goodwin, Diana'" <DGoodwin@CHSNJ.org>, "'Histonet'" <HistoNet@pathology.swmed.edu> |
Reply-To: | |
Date: | Thu, 23 Sep 1999 10:22:02 -0500 |
Content-Type: | text/plain; charset="iso-8859-1" |
Hi Diana,
Sorry that you are still confused. This has been a very confusing subject
and it has taken me quite awhile to half way understand. It is the
manufacturer who decides what the classification of the antibody will be.
Most antibodies are classified as IHC reagents and not subject to the
disclaimer. Most of the ASR's are antibodies against infectious disease and
prognostic markers, i.e. ER, PR, Ki-67 etc. If you need anymore help,
please let me know. Thanks
Debbie Jennings-Siena
-----Original Message-----
From: Goodwin, Diana [SMTP:DGoodwin@CHSNJ.org]
Sent: Wednesday, September 22, 1999 8:53 AM
To: 'Histonet'
Subject: FDA Final Rule
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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