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<DIV><SPAN class=165372217-18082003><FONT face=Arial color=#0000ff size=2>See
No. 4, Bullet 3 in CDRH Guidance for Industry, Analyte Specific Reagents; Small
Entity Compliance Guidance.</FONT></SPAN></DIV>
<DIV><SPAN class=165372217-18082003></SPAN> </DIV>
<DIV><SPAN class=165372217-18082003><SPAN class=165372217-18082003><FONT
face=Arial color=#0000ff size=2>Available at: <A
href="http://www.fda.gov/cdrh/oivd/guidance/1205.html">http://www.fda.gov/cdrh/oivd/guidance/1205.html</A></FONT></SPAN></SPAN></DIV>
<DIV><SPAN class=165372217-18082003><SPAN class=165372217-18082003><FONT
face=Arial color=#0000ff size=2></FONT></SPAN></SPAN> </DIV>
<DIV><SPAN class=165372217-18082003><SPAN class=165372217-18082003><FONT
face=Arial color=#0000ff size=2>Gary Gill</FONT></SPAN></SPAN></DIV>
<DIV><SPAN class=165372217-18082003><SPAN class=165372217-18082003><FONT
face=Arial color=#0000ff size=2></FONT></SPAN></SPAN> </DIV>
<DIV><SPAN class=165372217-18082003><SPAN class=165372217-18082003><FONT
face=Arial color=#0000ff size=2></FONT></SPAN> </DIV></SPAN>
<DIV class=OutlookMessageHeader dir=ltr align=left><FONT face=Arial
color=#0000ff size=2>-----Original Message-----<BR>From: Tapper, Sheila
[mailto:STapper@slhduluth.com]<BR>Sent: Monday, August 18, 2003 11:48 AM<BR>To:
histonet@lists.utsouthwestern.edu<BR>Subject: [Histonet] Ventana Benchmark-HPV
users<BR><BR></FONT></DIV>
<DIV class=MsoNormal dir=ltr><SPAN
style="FONT-SIZE: 10pt; mso-bidi-font-family: Arial"><FONT color=#0000ff>I am
wondering if anyone out there could help me with some information my pathologist
is looking for.<SPAN style="mso-spacerun: yes"> </SPAN>If you are
performing HPV testing on the Benchmark, are you putting some sort of disclaimer
on your report, since the probe is not IVD?<SPAN
style="mso-spacerun: yes"> </SPAN>Did you correlate the test to Digene, or
did you send the test to a lab that was performing HPV on the Benchmark for your
correlations, or both?<SPAN style="mso-spacerun: yes">
</SPAN><o:p></o:p></FONT></SPAN></DIV>
<DIV class=MsoNormal dir=ltr><SPAN
style="FONT-SIZE: 10pt; mso-bidi-font-family: Arial"><o:p><FONT
color=#0000ff> </FONT></o:p></SPAN></DIV>
<DIV class=MsoNormal dir=ltr><SPAN
style="FONT-SIZE: 10pt; mso-bidi-font-family: Arial"><FONT color=#0000ff>Thank
you!<o:p></o:p></FONT></SPAN></DIV>
<DIV class=MsoNormal dir=ltr><SPAN
style="FONT-SIZE: 10pt; mso-bidi-font-family: Arial"><o:p><FONT
color=#0000ff> </FONT></o:p></SPAN></DIV>
<DIV class=MsoNormal dir=ltr><SPAN
style="FONT-SIZE: 10pt; mso-bidi-font-family: Arial; mso-no-proof: yes"><FONT
color=#0000ff>Sheila Tapper HT(ASCP)<o:p></o:p></FONT></SPAN></DIV>
<DIV class=MsoNormal dir=ltr><FONT color=#0000ff><SPAN
style="FONT-SIZE: 10pt; mso-bidi-font-family: Arial; mso-no-proof: yes">St.
Luke’s Hospital</SPAN><o:p></o:p></FONT></DIV>
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color=#0000ff> </FONT></o:p></SPAN></DIV>
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