[Histonet] FDA statement for ASR antibodies used in immunohis tochemistry

Morken, Tim - Labvision tpmorken <@t> labvision.com
Thu Mar 10 11:59:57 CST 2005

Jim, you should put in the name of the lab that validates the antibody, not
the name of the company you buy it from. The ASR is, by definition,  not
validated by the vendor, so the vendor cannot be named as the lab that "...
developed..." and determined the "...performance characteristics..." that
lead to validation. 

Tim Morken
Lab Vision - Neomarkers

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-----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 9:44 AM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] FDA statement for ASR antibodies used in

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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