RE: [Histonet] ASR listing

From:"Jeff Gordon"

Gary, each of Cell Marque's antibodies are listed individually as either an IVD or an ASR (we don't carry any RUOs).  To make it easy for you, every one of Cell Marque's antibodies are IN VITRO DIAGNOSTIC antibodies with the following exceptions:

Hepatitis B Core Antigen
Hepatitis B Surface Antigen
HSV 1&2
Parvovirus B19
Pneumocystis Carinii

Basically, with our antibodies it comes down to all of the viral markers being ASRs, pneumocystis being an ASR, and the breast prognostic markers being ASRs.  As far as I know, ALL ASRs require a disclaimer when used in a clinical lab.  The rest that we carry so far (all the CD markers, all the keratins, all the hormonal markers, all the melanoma markers, etc.) are IVDs.  Other companies, depending on their use of each marker, may have different designations for their antibodies.  Unfortunately, I don't believe that there is a universal list for antibodies from all companies that lists whether they are IVD, ASR, or RUO.  Since we are geared primarily towards clinical labs, we carry antibodies approved for use in clinical settings.  Some companies may have the same antibodies (even the same clones) geared towards research labs, and theirs may be designated as Research Use Only.

Jeff Gordon
Cell Marque Corp.
1-800-665-7284, Ext. 12

-----Original Message-----
From: Gary Gill []
Sent: Wednesday, October 15, 2003 3:37 PM
To: 'Histonet'
Subject: [Histonet] ASR listing

Can anyone point me to a comprehensive listing of immunohistochemistry
reagents and their status as ASRs, IVDs, RUOs, and IUOs, and which ones
require the ASR disclaimer?  Thanks.

Gary Gill

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