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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device lipoprotein, low-density, antigen, antiserum, control
Regulation Description Low-density lipoprotein immunological test system.
Product CodeDFC
Regulation Number 866.5600
Device Class 2


Premarket Reviews
ManufacturerDecision
DIAZYME LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Low Test Results 1
Total Device Problems 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories, Inc II Jul-19-2019

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