High Throughput Dna Sequence Analyzer
The High Throughput DNA Sequence Analyzer is a clinical immunology device using next-generation sequencing (NGS) technology to perform targeted DNA sequencing of amplicons from a defined genetic region or set of regions, enabling high-volume genomic analysis in clinical settings. It falls under the Immunology medical specialty and is classified as a Class 2 device under regulation 862.2265, requiring 510(k) premarket notification. These systems are used for applications such as HLA typing, oncology panel testing, and infectious disease genomics. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PFF
- Device Class
- FDA class 2
- Regulation Number
- 862.2265
- Medical Specialty
- Immunology
- Review Panel
- TX
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.