| Device |
immunohistochemical assay, helicobacter pylori |
| Regulation Description |
Campylobacter fetus serological reagents. |
| 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 |
| Physical State |
Benchmark series instruments: BenchMark XT and BenchMark ULTRA auto slide stainer; recombinent rabbit monoclonal primary antibody directed against whole Helicobacter pylori organism |
| Technical Method |
Uses immunohistochemical staining methods to qualitatively detect Helicobacter pylori in paraffin-embedded, gastric biopsy tissue |
| Target Area |
Helicobacter pylori in paraffin-embedded, gastric biopsy tissue |
| Regulation Medical Specialty |
Microbiology |
| Review Panel |
Microbiology |
|---|
| Product Code | OWF |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.3110
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
|
Third Party Review
|
Accredited Persons
|
