[Histonet] Ventana Benchmark-HPV users

[Gary Gill]

See No. 4, Bullet 3 in CDRH Guidance for Industry, Analyte Specific
Reagents; Small Entity Compliance Guidance.
 
Available at: http://www.fda.gov/cdrh/oivd/guidance/1205.html
<http://www.fda.gov/cdrh/oivd/guidance/1205.html> 
 
Gary Gill
 
 
-----Original Message-----
From: Tapper, Sheila [mailto:STapper <@t> slhduluth.com]
Sent: Monday, August 18, 2003 11:48 AM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] Ventana Benchmark-HPV users


I am wondering if anyone out there could help me with some information my
pathologist is looking for.  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?  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?  
 
Thank you!
 
Sheila Tapper HT(ASCP)
St. Luke's Hospital
 
 
 
 
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