Definition: A High Throughput Sequencing Technology Performing Targeted DNA Sequencing Of Amplicons From A Defined Genetic Region Or A Subset Of Genes In Human Genomic DNA From A Clinical Sample.
| Device Type ID | 6016 |
| Device Name | High Throughput Dna Sequence Analyzer |
| Physical State | Sequencing Instrument And Associated Software |
| Technical Method | A High Throughput DNA Sequence Analyzer Is An Automated Clinical Multiplex Instrument System Intended To Prepare, Generate, Measure And Sort Signals In Order To Analyze DNA Molecules Of Amplicons From A Clinical Sample Such As Peripheral Whole Blood. |
| Target Area | Human Genomic DNA From A Clinical Sample |
| Regulation Description | High Throughput Genomic Sequence Analyzer For Clinical Use. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.2265 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PFF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 6016 |
| Device | High Throughput Dna Sequence Analyzer |
| Product Code | PFF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | High Throughput Genomic Sequence Analyzer For Clinical Use. |
| CFR Regulation Number | 862.2265 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
LIFE TECHNOLOGIES CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Illumina Inc | II | Sep-09-2014 |