Hi Jim: It is my understanding that the manufacturers were required to identify and notify their customers as to which of their reagents have been classified as ASRs by Nov. 1998. There were also required to modify their package inserts accordingly. All the manufacturers that we deal with have complied with this requirement. With regard to validation of these reagents, I would say yes you would need to since the FDA requires the following statement be placed on all clinical test results in which ASR reagents are used: "This test was developed and its performance characterisitics determined by (our laboratory's name). I has not been cleared or approved by the U.S. Food and Drug Administration". As far as I know this is only required for clinically testing. Hope this helps.
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