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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device anti-factor xa activity test system, apixaban
Regulation Description Heparin and direct oral factor Xa inhibitor drug test system.
Definition A heparin and direct oral factor Xa inhibitor drug test system is intended for the detection of heparin and direct oral factor Xa inhibitors in human specimens collected from patients taking heparin or direct oral factor Xa inhibitors. This device is intended to aid in the management of therapy in conjunction with other clinical and laboratory findings.
Product CodeQLU
Regulation Number 864.7295
Device Class 2


Premarket Reviews
ManufacturerDecision
INSTRUMENTATION LABORATORY CO.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Instrumentation Laboratory II Oct-19-2021
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