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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunoglobulin m kappa heavy and light chain combined
Definition Intended for the in-vitro quantification of IgM kappa concentration in human serum. The result is to be used with previously diagnosed igm Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.
Product CodePDE
Regulation Number 866.5510
Device Class 2


Premarket Reviews
ManufacturerDecision
THE BINDING SITE GROUP LTD
  SUBSTANTIALLY EQUIVALENT 2

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