[Histonet] ASR disclaimer question
I have information from the CAP website from 10/2003 that states: 'The FDA very clearly distinguishes ASR's from immunohistochemistry (IHC) reagents (final rule effective Aug. 17 1998). The FDA defines IHC's as "in vitro diagnostic devices....intended to identify, by immunological techniques, antigens in tissue or cytologic specimens." Unlike ASR's, IHC's are labeled by manufacturers with directions for use and performance indications.' I have checked with all of my vendors and all actually label their antibodies as IVD, research, or ASR. Those companies that have ASR antibodies available always use the letters ASR in the catalog number (at least all of the ones I have contacted). Using all of this information, our lab does not use ANY ASR's, so in you all's professional opinion, must we include the disclaimer?
For those of you that have been inspected lately, what specifically are the inspector's comments about this topic?
As always, it will be great to hear all of your feedback. Thanks, in advance.
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