Research Use Only Antibodies


I understand how to handle IVD and ASR labeled antibodies, my questions concern Research Use Only (RUO) labeled antibodies.

1.  Can we use RUO labeled antibodies in a clinical setting?  In a search of the archives, I have a yes and no answer.  

2.  One response mentioned that you can use RUO, but only with the disclaimer.  If so, do you also mention that certain antibodies in the panel are for RUO, because it would not make sense to use the same disclaimer for RUO and ASR antibodies.

3.  Three responses stated that you could not charge for RUO antibodies - is this so?  (Of course we do QA and QC with all antibodies, no matter how they come labeled.)

4.  Where can I get a direct answer for these questions and not a few pages of reading with the answer depending upon how each person interprets the regulation.

After all these years, one would think I would know these answers, but I still don't - sorry and thanks for any feedback.


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