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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device chromogranin a
Regulation Description Tumor-associated antigen immunological test system.
Definition In vitro test to measure Chromogranin A (CgA) as an aid in monitoring during the course of disease and treatment in patients with gastroentero-pancreatic neuroendocrine tumors.
Product CodeQXS
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
B.R.A.H.M.S GMBH, PART OF THERMO FISHER
  SUBSTANTIALLY EQUIVALENT 1

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