PHGClass II
Droplet Digital Pcr System
21 CFR 862.2570 / Clinical Chemistry
PHG is the FDA product code for Droplet Digital Pcr System, a class II device type, regulated under 21 CFR 862.2570. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- PHG
- Device name
- Droplet Digital Pcr System
- FDA 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.
- Regulation
- 21 CFR 862.2570
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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