# Reagents For Molecular Diagnostic Test Systems
> **Product code: PFT** · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.3800
## Classification
- **FDA Product Code:** PFT
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 862.3800
- **Review panel:** TX
- **Medical specialty:** Clinical Chemistry
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A kit that is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The kit is intended for use as part of molecular diagnostic test systems.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 13
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PFT)
---
*AI Analytics · CC0 1.0*