OWFClass I

Immunohistochemical Assay, Helicobacter Pylori

21 CFR 866.3110 / Microbiology

OWF is the FDA product code for Immunohistochemical Assay, Helicobacter Pylori, a class I device type, regulated under 21 CFR 866.3110. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2011-08-25, and 2 recalls.

Classification record

Product code: OWF
Device name: Immunohistochemical Assay, Helicobacter Pylori
FDA 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
Regulation: 21 CFR 866.3110
Device class: Class I
Review panel: Microbiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 1
Ingested recalls: 2

Clearances, product code OWF

By decision year

1 clearance under product code OWF with a decision year between 2011 and 2011, 2011 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OWF by decision year
Year	Clearances
2011	1

Applicants with the most clearances

Product code OWF

Applicants holding the most 510(k) clearances under product code OWF
Applicant	Clearances
Ventana Medical Systems Inc	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code OWF

K101234Class IVentana Anti-Helicobacter Pylori (Sp48) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc. / cleared 2011-08-25

Recent recalls

Product code OWF

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)