DeviceClearance

Product code OWF— Microbiology

VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY

Classification name
Immunohistochemical Assay, Helicobacter Pylori
Device class
Class 1
Regulation
21 CFR 866.3110
Advisory panel
Microbiology
Total cleared
1
First cleared
Most recent

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”

— U.S. Food and Drug Administration, device classification record for product code OWF under 21 CFR 866.3110, via openFDA

Market context for product code OWF

FDA has cleared 1 device under product code OWF, all in 2011, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code OWF

Recent clearances under product code OWF

Data sourced from openFDA. This site is unofficial and independent of the FDA.