Definition: This Device Is Intended To Detect Her2 Gene Amplification In Formalin-fixed, Paraffin-embedded Breast Carcinoma Tissue Sections Using Chromogenic In Situ Hybridization And Brightfield Microscopy. Indicated As An Aid In The Assessment Of Patients For
| Device Type ID | 3134 |
| Device Name | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer |
| Physical State | Brightfield Microscopy |
| Technical Method | Chromogenic In Situ Hybridization |
| Target Area | Breast Carcinoma Tissue Sections |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NYQ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3134 |
| Device | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer |
| Product Code | NYQ |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Ingredient Or Reagent Problem | 1 |
False Positive Result | 1 |
Chemical Problem | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cell Marque Corporation | II | Jun-01-2017 |
| 2 | Dako North America Inc. | II | Jun-29-2016 |
| 3 | Dako North America Inc. | II | Feb-26-2014 |