13485:2016
background

Ustar


Overview

 

Ustar Biotechnologies (Hangzhou) Ltd. was founded in 2005 and specializes in the research, development, production, and sales of innovative point-of-care molecular diagnostic (POCT) technologies and products. The company develops molecular testing solutions for clinical diagnostics, disease prevention.

Ustar's portfolio combines molecular diagnostic systems with compatible reagents for nucleic acid amplification and detection. Its cartridge-based workflow integrates nucleic acid extraction, purification, and amplification in a fully sealed format, supporting a simplified sample-in, result-out process.

Expertise in IVD and Molecular Diagnostics

Ustar Biotechnologies' expertise encompasses the following core capabilities:

Point-of-Care Molecular Testing: Development of integrated molecular diagnostic platforms for use across primary healthcare, hospitals, laboratories, and public-health settings.

Integrated Nucleic Acid Workflow: Sealed cartridge technology designed to combine sample processing and nucleic acid amplification in a streamlined, automated workflow.

Flexible Testing Platforms MultNAT supports multiplex, drug-resistance, and quantitative testing, while PortNAT and EasyNAT support different molecular testing workflows and care settings.Broad Application Coverage: Molecular assays spanning syndromic, respiratory, gastrointestinal, tuberculosis and emerging infectious diseases, blood virology, women's and sexual health, tropical fever, hospital-acquired infections, and livestock and veterinary diseases.
Quality and Innovation:
More than 90 international and domestic patent applications, including 62 granted patents; a GMP-certified clean production workshop; ISO 13485:2016 and MDSAP certifications; and an expanding international regulatory and market presence.

 Global Presence

Ustar's products and technologies have served more than 3,000 medical institutions and have been exported to over 90 countries. The company is headquartered in Hangzhou, China, and continues to expand molecular testing solutions for healthcare and public-health needs worldwide.

The company reports NMPA Class III certification for two devices and more than ten reagents, CE IVDR certification for more than ten reagents, and additional international certifications across selected products. Its PortNAT and EasyNAT monkeypox molecular POCT reagents have also received WHO Emergency Use Listing (EUL).

Partnership with JAT Medical

JAT Medical partners with Ustar Biotechnologies to expand its IVD and POCT portfolio and bring molecular diagnostic solutions closer to healthcare providers across Saudi Arabia.

The collaboration connects Ustar's molecular testing platforms and reagent technologies with JAT Medical's local market knowledge, clinical education, technical support, and healthcare-provider relationships. Together, we aim to support more efficient diagnostic workflows and more informed clinical decision-making across the Kingdom.