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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)
Product CodeMOB
Regulation Number 866.5660
Device Class 2


Premarket Reviews
ManufacturerDecision
AESKU.DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
AESKU.DIAGNOSTICS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDICAL DIAGNOSTICS (BMD) SA
  SUBSTANTIALLY EQUIVALENT 1
EUROIMMUN US INC
  SUBSTANTIALLY EQUIVALENT 2
EUROIMMUN US, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMMCO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
INOVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 1
PHADIA US INC.
  SUBSTANTIALLY EQUIVALENT 1

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