[Histonet] FDA statement for ASR antibodies used inimmunohistochemistry

Joe Nocito JNocito <@t> Pathreflab.com
Thu Mar 10 16:45:47 CST 2005


Jim,
we just had a CAP inspection and the inspector was looking just for that
statement. We have our lab name in the disclaimer because we were the ones
that performed all the testing.

Joe Nocito, BS, HT(ASCP) QIHC
Histology Manager
Pathology Reference Lab
San Antonio, TX

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu]On Behalf Of Vickroy,
Jim
Sent: Thursday, March 10, 2005 11:44 AM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] FDA statement for ASR antibodies used
inimmunohistochemistry


When using the FDA disclaimer in surgical reports when using an FDA
disclaimer are people using their own lab name in the disclaimer
statement (since we now have to validate the use of ASR's and RUO's), or
are they using the vendor's name of the company that developed the
antibody, such as Cell Marque, Ventana, BD, etc.



Jim Vickroy

Memorial Medical Center

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