Droplet Digital Pcr System
The Droplet Digital PCR System is an in vitro diagnostic amplification and detection system intended for the amplification, qualitative and quantitative detection, and analysis of nucleic acid samples isolated from clinical specimens partitioned into nanoliter or smaller droplets using a water-oil emulsion technique. It is an FDA Class 2 device regulated under 21 CFR 862.2570, requiring 510(k) clearance, within the Clinical Chemistry (CH) specialty. The product code is PHG. The system is intended for use with separately cleared or approved in vitro diagnostic assays that specify its use.
Research product code PHG in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PHG
- Device Class
- FDA class 2
- Regulation Number
- 862.2570
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.