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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Benchmark series instruments: BenchMark XT and BenchMark ULTRA auto slide stainer; recombinent rabbit monoclonal primary antibody directed against whole Helicobacter pylori organism
Technical Method Uses immunohistochemical staining methods to qualitatively detect Helicobacter pylori in paraffin-embedded, gastric biopsy tissue
Target Area Helicobacter pylori in paraffin-embedded, gastric biopsy tissue
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOWF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.3110
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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