This document specifies the classification, requirements, test methods, labels, identification and instructions for use, packaging, transportation and storage of digital polymerase chain reaction analysis systems. This document applies to equipment that generates hundreds to millions of independent reaction units for nucleic acid samples in a single droplet or single nucleic acid molecule. The analysis system includes a microdroplet generation module, a polymerase chain reaction module, and a microdroplet detection module. wait.
YY/T 1918-2023 history
2023YY/T 1918-2023 Digital polymerase chain reaction analysis system