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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search Show TPLC since Back To Search Results
Device ldl & vldl precipitation, hdl
Regulation Description Lipoprotein test system.
Product CodeLBR
Regulation Number 862.1475
Device Class 1


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS OPERATIONS (RDO)
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Low Test Results 3
High Test Results 1
Total Device Problems 4

Recalls
Manufacturer Recall Class Date Posted
1 Medtest Holdings, Inc. III Nov-05-2018
2 Pointe Scientific, Inc. III Sep-14-2015
3 Roche Diagnostics Operations, Inc. II Jun-27-2015
4 Sterling Diagnostics, Inc. III Dec-29-2016

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