FDA product code PHG: Droplet Digital Pcr System
PHG is the FDA product code for droplet digital pcr system. It is a Class II device, regulated under 21 CFR 862.2570 and reviewed by the Clinical Chemistry panel. Devices under PHG reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Droplet Digital Pcr System |
| Device class | Class II |
| Regulation | 21 CFR 862.2570 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for PHG devices
openFDA lists no recalls for product code PHG.
Frequently asked questions
What is FDA product code PHG?
PHG is the FDA product code for droplet digital pcr system. It is a Class II device, regulated under 21 CFR 862.2570 and reviewed by the Clinical Chemistry panel.
What device class is PHG?
Class II, regulation 21 CFR 862.2570. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PHG
- Run a recall and safety report across every PHG manufacturer
- Watch product code PHG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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