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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device data acquisition software
Regulation Description Instrumentation for clinical multiplex test systems.
Definition Software that integrates a network of sample pooling instruments, and manages the overall blood analysis sample workflow. Software acquires and processes data from various donor screening, diagnostic, multiplex assay instruments.
Product CodePQQ
Regulation Number 862.2570
Device Class 2


Premarket Reviews
ManufacturerDecision
STRATEC BIOMEDICAL UK LIMITED
  SUBSTANTIALLY EQUIVALENT 2

Recalls
Manufacturer Recall Class Date Posted
1 Tosoh Smd Inc II Feb-22-2017
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