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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, anticardiolipin immunological
Product CodeMID
Regulation Number 866.5660
Device Class 2


Premarket Reviews
ManufacturerDecision
BIO-RAD LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
IMMCO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INOVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
PHADIA US INC.
  SUBSTANTIALLY EQUIVALENT 2
ZEUS SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bio-Rad Laboratories, Inc. II May-10-2023
2 Calbiotech Inc II Mar-05-2010
3 Euro Diagnostica AB III Aug-23-2018
4 Phadia US Inc III Aug-28-2012
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