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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device immunoglobulin m lambda heavy and light chain combined
Definition Intended for the in-vitro quantification of IgM lambda 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 CodePDF
Regulation Number 866.5510
Device Class 2

MDR Year MDR Reports MDR Events
2018 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3 3

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