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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test system, antineutrophil cytoplasmic antibodies (anca)
Regulation Description Multiple autoantibodies immunological test system.
Product CodeMOB
Regulation Number 866.5660
Device Class 2


Premarket Reviews
ManufacturerDecision
ZEUS SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Phadia Ab II Jan-24-2024
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