QF-CMV FDA Approval

"floyd" asks:

would anyone happen to know how far down the track cst is in getting fda approval for qf-cmv? 

I am advised that the data for the submission for FDA approval for QF-CMV is in the final stages of preparation. This will be a 501K approval and therefore will not take anywhere near as long as the approval for QFT-TB Gold took. I imagine months, rather than years.


Don't forget that we already have CE-Mark for Europe and can therefore sell in Europe immediately.