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