[Histonet] Ventana Benchmark-HPV users
garygill <@t> dcla.com
Mon Aug 18 12:23:17 CDT 2003
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
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?
Sheila Tapper HT(ASCP)
St. Luke's Hospital
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