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Immunohistochemical Assay, Helicobacter Pylori

FDA product code OWF · 1 cleared devices

Class 1 Microbiology
Regulation
21 CFR 866.3110
Review panel
MI
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2011-08-25 – 2011-08-25

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

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