OWF

Immunohistochemical Assay, Helicobacter Pylori

Product code

OWF

Device name

Immunohistochemical Assay, Helicobacter Pylori

Device class

Class 1

21 CFR

21 CFR 866.3110

Medical specialty

Microbiology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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

Definition text from the FDA device classification database (U.S. federal government work, public domain).