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ISO and Human Diagnostic Assays

Bryan Kiehl GenBio at cts.com
Wed Oct 9 03:47:40 EST 1996

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 distributors.

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.
Bryan Kiehl
GenBio, San Diego
GenBio at msn.com

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