Hoyotek Expands International Portfolio for Its COVID-19 Test Series
On May 19, 2026, the COVID-19 Antigen Rapid Test Kit (Colloidal Gold) manufactured by Hoyotek Biomedical Co., Ltd. (China) was certified by the Australian TGA and included in the ARTG under Registration No. 526871.
Classified as a Class 3 medical device under the TGA's stringent standards, the product has undergone rigorous development, validation, clinical evaluation, and registration processes that fully comply with Australian regulatory requirements.
This approval represents another significant regulatory achievement for Hoyotek Biomedical in the Australian market, following its COVID-19 triple (COVID-19/Flu A/Flu B) and quadruple (COVID-19/Flu A/Flu B/RSV) combo test kits.The kit offers easy operation, rapid results, high sensitivity, and strong specificity, making it suitable for rapid self-testing and large-scale screening.
Hoyotek Biomedical remains committed to quality and innovation, expanding its global presence to support public health.