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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device anti-dna antibody, antigen and control
Product CodeLSW
Regulation Number 866.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
AESKU DIAGNOSTICS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
INOVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Meningitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Phadia US Inc II Feb-11-2021
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