FDA/IVD/CAP/???

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I'm hoping that someone from the clinical realm (USA), including any vendors,
might comment on the story in the December issue of CAP Today, entitled "Final
blueprint for unapproved reagents".

After reading the it, I'm not at all clear as to what is "new", based on the
recent meeting on IVD regulation that was discussed in the article.

I'd like to know if, and how, it will impact the "end users" in clinical labs.

Thanks in advance,

Marc Langweiler
marcl@dartmouth.edu

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CD ROM Vol 2 was produced by staff at the Purdue University Cytometry Laboratories and distributed free of charge as an educational service to the cytometry community. If you have any comments please direct them to Dr. J. Paul Robinson, Professor & Director, PUCL, Purdue University, West Lafayette, IN 47907. Phone:(317) 494-0757; FAX (317) 494-0517; Web http://www.cyto.purdue.edu EMAIL robinson@flowcyt.cyto.purdue.edu