RE: [Histonet] Ventana Benchmark-HPV users

From: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
 
Gary Gill
 
 
-----Original Message-----
From: Tapper, Sheila [mailto:STapper@slhduluth.com]
Sent: Monday, August 18, 2003 11:48 AM
To: histonet@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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