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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device igm (mu chain specific), antigen, antiserum, control
Regulation Description Immunoglobulin (light chain specific) immunological test system.
Product CodeDAO
Regulation Number 866.5550
Device Class 2

Device Problems
Incorrect Or Inadequate Test Results 2
High Test Results 1
Total Device Problems 3


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