BiOptic Inc. was listed on Taiwan’s Emerging Stock Board from Q4, 2021
2021-12-28
BiOptic Inc.’s self-developed COVID-19 test kit has been formally submitted to the European Union a few days ago to apply for in vitro diagnostic medical device (CE-IVD) certification.
Congratulations! BiOptic has won the 28th Taiwan Small and Medium Enterprises Innovation Award!
2021-11-22
BiOptic has won the 28th Taiwan Small and Medium Enterprises Innovation Award for its "Qsep1-Lite Bio-Fragment Analyzer" from the Ministry of Economic Affairs, R.O.C.
【BiOptic x CatchGene Webinar】Biotechnologies of Automated High-Yield Capturing and Quality Control
2021-06-01
With the continuous development of molecular detection technology, circulating cell-free DNA (cfDNA), FFPE tissue DNA and stool DNA have become important targets. However, since cfDNA is rare, FFPE DNA is fragmental, and stool DNA is rich in inhibitors, it is a very laborious process to purify and perform quality control of these types of samples. .....
BiOptic has certificated by UL in conformance with FDA 21 CFR Part 11
2021-02-19
The software system of Qsep series bio-fragment analyzer, Q-Analyzer, which is developed by BiOptic, has certificated by UL in conformance with FDA 21 CFR Part 11 in Jan 2021. The FDA guidelines for Data Integrity include the requirement for compliance for the storage of electronic records. Nearly all the medical-related industries follow this standard, which gains on the safety of information security and data management of the product. The data retained in this standard can be used as an effective source for future tracking.
