Definition: Complete Gene Expression Profiling Accessory Reagent Kits Include All Components Necessary To Perform Transcript Synthesis, Fluorescent Labeling, And Detection And Are Intended To Carry Out All Processing Steps For Separately Cleared Gene Expression
| Device Type ID | 649 |
| Device Name | Complete Gene Expression Profiling Accessory Reagents |
| Physical State | Should Not Include Reagents To Perform Only Part Of Gene Expression Assay Processing Steps (e.g., Transcript Synthesis But Not Labeling) Or Only Individual Components Insufficient To Carry Out All Processing Steps Or Only RNA Extraction And Purificat |
| Technical Method | Complete Accessory Reagents For Gene Expression Profiling Are Intended, Designed, And Optimized To Carry Out All Assay Processes. The Reagents Include All Components, Including Enzyme Mixes, Labeling Reagents, Reaction Buffers, And Purification Reage |
| Target Area | Not Applicable. |
| Regulation Description | Instrumentation For Clinical Multiplex Test Systems. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.2570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OVA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |