PHG — Droplet Digital Pcr System Class II
FDA product code PHG covers "Droplet Digital Pcr System", a Class II medical device regulated under 21 CFR 862.2570. Submissions are reviewed by the Clinical Chemistry panel.
Classification Details
- Product Code
- PHG
- Device Class
- Class II
- Regulation Number
- 862.2570
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.