PHG
- Product code
- PHG
- Device name
- Droplet Digital Pcr System
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.2570
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K) Exempt
FDA classification definition
A droplet digital PCR system is an in vitro diagnostic amplification and detection test system that is intended for the amplification, detection (qualitative and quantitative), and analysis of nucleic acid samples, isolated from clinical specimens, which have been partitioned into nanoliter or smaller droplets using a water oil emulsion technique. A droplet digital PCR system is intended for use with cleared or approved in vitro diagnostic assays which specify its use.
Official FDA classification page: PHG
Classification and pathway per current FDA publications. Data from openFDA (CC0).