PFF — High Throughput Dna Sequence Analyzer Class II
FDA product code PFF covers "High Throughput Dna Sequence Analyzer", a Class II medical device regulated under 21 CFR 862.2265. Submissions are reviewed by the Immunology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PFF
- Device Class
- Class II
- Regulation Number
- 862.2265
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Immunology
- Implant
- No
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.