OWF — Immunohistochemical Assay, Helicobacter Pylori Class I

FDA Device Classification

Classification Details

Product Code
OWF
Device Class
Class I
Regulation Number
866.3110
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K101234ventana medical systemsVENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODYAugust 25, 2011