Recently, three quantitative PCR instruments from Rocgene have successfully obtained FDA Listing and UKCA Certification. Following the EU CE certification in 2021, this marks another important step forward for Rocgene in the global market. Congratulations!

The three models certified by the US FDA and UK UKCA are:

FDA Official Query Result

UK UKCA Certification

About FDA

The FDA (Food and Drug Administration) is an agency under the U.S. Department of Health and Human Services (DHHS) and Public Health Service (PHS).

As a global authority for medical device regulation, the FDA is authorized by the U.S. Congress to oversee food, drugs, medical devices, radiation‑emitting products, vaccines, blood and biological products, veterinary products, cosmetics, and tobacco. Medical devices are regulated by the Center for Devices and Radiological Health (CDRH), which supervises manufacturing, packaging, and distribution to ensure safety and effectiveness.

About UKCA

UKCA stands for UK Conformity Assessed. On February 2, 2019, the UK announced the UKCA marking scheme for a no‑deal Brexit. It became fully effective on January 1, 2021.

UKCA is the product certification mark introduced after Brexit, replacing the EU CE mark for products placed on the market in Great Britain (England, Wales, and Scotland; excluding Northern Ireland). The UKCA mark confirms compliance with UK regulatory requirements.

Achieving dual certification from the U.S. FDA and UK UKCA for multiple products fully reflects international recognition of Rocgene’s quality and service. It further strengthens Rocgene’s core competitiveness in molecular diagnostics and marks the official strategic launch of its global expansion.

As a key player in domestic molecular diagnostics, Rocgene’s comprehensive genetic testing solutions are trusted by over 1,000 customers worldwide, with core product installations reaching tens of thousands. Committed to developing world‑leading life science and diagnostic products, Rocgene will continue investing in R&D and technological innovation to deliver even higher‑quality products and services.

About Rocgene

Founded in 2016, Rocgene (Beijing) Technology Co., Ltd. is a high‑tech biotechnology company established by scientists and industry professionals, driven by core technologies. Rocgene transforms cutting‑edge life science research into clinically applicable products, developing proprietary research and molecular diagnostic tools.

Rocgene is certified as a National High‑Tech Enterprise and Zhongguancun High‑Tech Enterprise. It holds 26 patents (12 invention, 9 utility model, 5 design) and 32 software copyrights. It operates a clean workshop of over 10,000 ㎡ in Xuzhou High‑Tech Zone. With courage to transcend and ambition to excel, Rocgene aims to be a forward‑looking industry leader.

Rocgene Product Series