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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


Premarket Reviews
ManufacturerDecision
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1

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