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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device st2 assay
Definition Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.
Product CodeOYG
Regulation Number 862.1117
Device Class 2


Premarket Reviews
ManufacturerDecision
CRITICAL CARE DIAGNOSTICS, INC. (DBA CRITICAL DIAG
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Critical Diagnostics III Jul-13-2012
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