Universal Biosensors, Inc. (UBI) operates as a specialist biosensors company.
The company focuses on commercializing a range of biosensors in oenology (wine industry), human health, including oncology, coagulation, COVID-19, women's health and fertility, non-human and environmental testing using its patented platform technology and hand-held point of use devices.
The company specializes in the design and development of electrochemical cells (strips) used in conjunction with point-of-use device...
Universal Biosensors, Inc. (UBI) operates as a specialist biosensors company.
The company focuses on commercializing a range of biosensors in oenology (wine industry), human health, including oncology, coagulation, COVID-19, women's health and fertility, non-human and environmental testing using its patented platform technology and hand-held point of use devices.
The company specializes in the design and development of electrochemical cells (strips) used in conjunction with point-of-use devices that are used in various industries such as healthcare (point-of-care), wine, food, and agriculture.
The company operates in the high growth, point-of-care segment of the global in vitro diagnostics (IVD) industry and oenology (wine industry) and other industries where point-of-use devices are or can be used.
The company focuses on the development, manufacture, and commercialization of a range of point-of-use devices for measuring different analytes across different industries. The company's operations are in Australia, the United States, Europe, and Canada.
The company continues to demonstrate the broader application of its technology platform for markets with significant commercial potential and has developed products in blood glucose, a coagulation Prothrombin Time International Normalized Ratio ('PT-INR') test and chemical tests for the wine industry.
The company continues to develop an oncology biosensor used for the detection, staging, and monitoring of cancer, and an Aptamer based platform to be used for SARS-CoV-2 N-Protein (which is the virus that causes COVID-19) ('COVID-19 test'), female fertility and the environment.
The company uses various channels to sell its products and they include direct sales and the engagement of distributors and agents.
Principal Products and Services
The company is the manufacturer and distributor of PT-INR coagulation test strips and devices (Xprecia Stride and Xprecia Prime), used to monitor the effect of the anticoagulant therapy warfarin. Xprecia Stride and Xprecia Prime are medical devices.
The company is the manufacturer and distributor of all the Sentia wine testing products which includes, Free SO?, Malic Acid, Glucose, and Fructose. Sentia is a non-medical device.
The company is the manufacturer and distributor of the Petrackr which is a blood glucose test to be used in cats and dogs.
The company's wholly owned Canadian operating subsidiary, Hemostasis Reference Laboratory Inc. (HRL), provides non-diagnostic laboratory services and performs coagulation testing services.
The company's wholly owned Australian operating subsidiary, Universal Biosensors Pty Ltd (UBS), continues to conduct research and development to demonstrate the broader application of its technology platform.
Regulatory Clearances
UBI's medical device products and operations are subject to regulation by the U.S. Food and Drug Administration (FDA) and various other federal and state agencies, as well as by foreign governmental agencies. These agencies enforce laws and regulations that govern the development, testing, manufacturing, labelling, advertising, marketing and distribution, and market surveillance of UBI's medical devices products. These products are also developed, manufactured and sold under an international quality system standard known as ISO 13485.
UBI's Petrackr (animal device) and Sentia (non-medical) products are subject to regulation by product safety regulations by many government agencies in multiple jurisdictions. These agencies enforce laws and regulations that govern the safety aspects for development, testing, manufacturing, labelling, advertising, marketing and distribution, and market surveillance of UBI's products. These products are also developed, manufactured, and sold under an international quality system standard known as ISO 9001.
UBI actively maintains FDA/ISO Quality Systems that establish standards for its product design, manufacturing, and distribution processes.
Trademarks
The company owns the 'SENTIA' trademark, which it uses to market its wine testing products and the 'PETRACKR' trademark which it uses to market its blood glucose test to detect and monitor diabetes in non-humans.
History
Universal Biosensors, Inc. was founded in 2001. The company was incorporated in the state of Delaware in 2001.
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