FW: ventana nexes - her2neu
|From:||"Wilson, Denise" <DWilson@brookdale.edu>|
I am more confused than ever by this answer!
> I am writing to clear up some confusion that exists regarding the
> status of one of our products, Ventana c-erbB-2 Primary Antibody, Clone
> CB11. Currently this product is marketed as an Analyte Specific Reagent.
> It is, however, submitted to the FDA for review to obtain IVD labeling.
> The type of submission filed with the FDA was a Premarket Approval, or
> This is due to the fact that the FDA has classified this product as a
> III Device. Under 21CFR 864.1860 we are required by law to submit a PMA
> have it approved prior to marketing this product as an IVD test. The FDA
> will not accept a 510(k) submission for immunohistochemical assays for
> Her-2/neu. Neither Ventana nor any other company may submit a 510(k).
> Hope this clears up any misinformation.
> BJ Kerns
> Director of Worldwide Strategic Marketing
> Advanced Staining Reagents
> 3865 N Business Center Drive
> Tucson, AZ 85705
> 1-800-227-2155 ext. 3577
> -----Original Message-----
> From: Wilson, Denise [mailto:DWilson@brookdale.edu]
> Sent: Tuesday, September 19, 2000 9:33 AM
> To: 'email@example.com'
> Subject: ventana nexes - her2neu
> > I am considering getting the Ventana Nexes for immuno but recently came
> > accross some disturbing information. I was told that the her2Neu from
> > ventana was not FDA approved, and that a doctor cannot prescribe
> > based on this result. Does anyone out there know anything about this?
> > Please enlighten me on this subject, and while you are at it, pros and
> > cons of the nexes and Dako machines.
> > > Thanks
> > > Denise Wilson
> > > Brookdale Hospital
> > >
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