Definition: The BRAF Mutation Kit Is A Multiplex Qualitative In Vitro Diagnostic Device To Identify Specific BRAF Mutations By Multiplex Polymerase Chain Reaction Of Genomic DNA Extracted From Formalin-fixed Paraffin-embedded (FFPE) Colorectal Cancer Or Fine Nee
| Device Type ID | 5044 |
| Device Name | Braf Mutation Kit |
| Physical State | Multiplex Qualitative DNA Mutation Amplification And Detection Test System. Should Not Include Products Not Intended For Export Only Or For Products Intended For Re-importation Into The USA. |
| Technical Method | The Test Uses Multiplex Qualitative Polymerase Chain Reaction (PCR) And A Multiplex Test System (e.g., Liquid Bead Array Cytometry, Etc.) To Amplify And Detect Specific BRAF Mutations. |
| Target Area | Formalin-fixed Paraffin-embedded (FFPE) Colorectal Cancer Or Fine Needle Aspirated (FNA) Thyroid Tissue. |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | Contact ODE |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | PAN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |