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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device immunohistochemical assay, helicobacter pylori
Regulation Description Campylobacter fetus serological reagents.
Definition Anti-helicobacter pylori rabbit monoclonal primary antibody is designed to qualitatively detect the presence of helicobacter pylori in formalin-fixed, paraffin-embedded gastric biopsy tissue via light microscopy. Immunohistochemical staining with this antibody product may aid in the diagnosis of helicobacter pylori infection. This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls. This antibody is intended for in vitro diagnostic (IVD) use
Product CodeOWF
Regulation Number 866.3110
Device Class 1


Premarket Reviews
ManufacturerDecision
Ventana Medical Systems Inc
  SUBSTANTIALLY EQUIVALENT 2

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