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ISO and Human Diagnostic Assays

MHughes77 at aol.com MHughes77 at aol.com
Fri Oct 11 03:49:23 EST 1996

I am very interested in receiving the comments by newsgroup members on this
topic too.  Please post replies publicly to the newsgroup
(diagnost at net.bio.net).


Mark Hughes
RapidTest Diagnostics International, Inc.


In a message dated 96-10-09, Bryan Kiehl wrote:

> I work in a medium size company that makes immunoassays for both the US and
>  European markets. In most cases we sell these through various
>  We comply with GMP and GLP, but have only been monitoring the ISO regs. At
>  this time, it is my understanding that ISO does not apply to most
>  diagnostic kits.
>  I would be interested in various comments about the following subjects:
>  CE marks; can they be established without ISO registration
>  ISO as it relates to in vitro diagnostics
>  Any other related issues.

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