PFF
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- High Throughput Dna Sequence Analyzer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.2265
- Medical specialty
- Immunology
- FDA 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.
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| Record | Firm | Date |
|---|---|---|
| Ion PGM Dx System (K170299) | Life Technologies Corporation | 2017-06-22 |
| ILLUMINA MISEQDX PLATFORM (DEN130011) | Illumina, Inc. | 2013-11-19 |
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