Sebia receives U.S. FDA Clearance for the FLC Kappa & Lambda assays
The next generation instrument for screening hemoglobin disorders in newborns.
Sebia has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the FLC Kappa & Lambda assays.
These are the first EIA tests receiving 510(k) from the FDA for the quantitative detection of both kappa and lambda free light chains (FLC) in human serum specimens, intended for both aid of diagnosis and monitoring of #Multiple Myeloma and Immunoglobulin Light-Chain (AL-) amyloidosis.
To learn more, consult the press release :
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