CLIA rules on antibody expiration dates

Antony Bakke (bakkea@ohsu.EDU)
Fri, 20 Oct 95 15:29:03 PST

I have a question for the clinical flow cytometrists in the group.
The final CLIA rules state that reagents are not to be used past
their expiration date unless the FDA grants an exception. This is a
problem with expensive antibodies. Has FDA made any exceptions for
antibodies if their reactivity can be varified in the lab?

I'd appreciate any opinions, definite information or someone to
contact.

Thanks, Tony Bakke
bakkea@ohsu.edu
(503) 494-4687

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CD ROM Vol 2 was produced by staff at the Purdue University Cytometry Laboratories and distributed free of charge as an educational service to the cytometry community. If you have any comments please direct them to Dr. J. Paul Robinson, Professor & Director, PUCL, Purdue University, West Lafayette, IN 47907. Phone:(317) 494-0757; FAX (317) 494-0517; Web http://www.cyto.purdue.edu EMAIL robinson@flowcyt.cyto.purdue.edu