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 Thi
| Device Type ID | 3543 |
| Device Name | Immunohistochemical Assay, Helicobacter Pylori |
| 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 Description | Campylobacter Fetus Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3110 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OWF |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3543 |
| Device | Immunohistochemical Assay, Helicobacter Pylori |
| Product Code | OWF |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Campylobacter Fetus Serological Reagents. |
| CFR Regulation Number | 866.3110 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cell Marque Corporation | II | Jun-01-2017 |
| 2 | Ventana Medical Systems Inc | I | Sep-14-2018 |