Tim:
 
I did not mean to imply that all companies use the ASR, IVD, RUO in their catalog numbers.  What I meant was that the companies that I spoke with, some you mention by the way,  told me that they do list ASR in the catalog number, if the reagent is such;  specifically meaning that if they had a catalog number without ASR in it, then it was to be considered IVD or RUO.  Hope this clears it up.
 
Susan

"Morken, Tim - Labvision"  wrote:
Susan, Our company does not use "ASR", "IVD" or "RUO" in the catalog number,
nor do any of the other top antibody vendors (DAKO, Novocastra, Zymed,
BioGenex, BioCare), so rather than depend on catalog numbers, look at the
datasheet that comes with the antibody. The datasheet should clearly state
either ASR, IVD or RUO use. Also, the label on the antibody vial should
clearly state "in vitro diagnostic device" if it is an IVD, ASR or RUO. If
it does not, then contact the vendor to clarify.

Tim Morken
Product Development
Lab Vision - Neomarkers
47790 Westinghouse Dr.
Fremont, CA 94539 USA

tel: 01-510-991-2840
fax: 01 510-991-2826
email: tpmorken@labvision.com
web: www.labvision.com

Free webhosting for US State Histotechnology Societies:
http://www.labvisioncorp.com/demowebsite/index.cfm

-----Original Message-----
From: histonet-bounces@lists.utsouthwestern.edu
[mailto:histonet-bounces@lists.utsouthwestern.edu] On Behalf Of Histology
SLU
Sent: Tuesday, March 15, 2005 7:14 AM
To: histonet@lists.utsouthwestern.edu
Subject: [Histonet] ASR disclaimer question


Hello All:

I have information from the CAP website from 10/2003 that states: 'The FDA
very clearly distinguishes ASR's from immunohistochemistry (IHC) reagents
(final rule effective Aug. 17 1998). The FDA defines IHC's as "in vitro
diagnostic devices....intended to identify, by immunological techniques,
antigens in tissue or cytologic specimens." Unlike ASR's, IHC's are labeled
by manufacturers with directions for use and performance indications.' I
have checked with all of my vendors and all actually label their antibodies
as IVD, research, or ASR. Those companies that have ASR antibodies
available always use the letters ASR in the catalog number (at least all of
the ones I have contacted). Using all of this information, our lab does not
use ANY ASR's, so in you all's professional opinion, must we include the
disclaimer?

For those of you that have been inspected lately, what specifically are the
inspector's comments about this topic?

As always, it will be great to hear all of your feedback. Thanks, in
advance.

Susan

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