# High Throughput Dna Sequence Analyzer
> **Product code: PFF** · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 862.2265
## Classification
- **FDA Product Code:** PFF
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 862.2265
- **Review panel:** TX
- **Medical specialty:** Immunology
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 10
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PFF)
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