Prometheus, a Chinese company with headquarters in Hangzhou, is dedicated to developing genuine partnerships with its clients by offering prompt, excellent, and precise diagnostics products and services. Prometheus is currently the preferred vendor for many consumers both domestically and abroad because of its high quality requirements, excellent product design, and one-stop shop services. Prometheus covers a broad range of topics, including those related to drug tests, women's health, cardiac markers, infectious disease, and tumor markers.
The Prometheus factory has received certification for ISO 9001:2008 and IS013485:2003. The US FDA investigated Prometheus' manufacturing facility in November 2012, but no 483 form was produced.
The company currently enjoys a solid sales record for its goods in the United States, Europe, Australia, New Zealand, Chile, Brazil, and other nations, earning it the title of "reliable product supplier" on the international market.
Become a top company in the diagnostic industry.
Committed to health and providing world-class products.
Providing quality services to customers, creating development opportunities for employees, embodying long-term value for society, and pursuing the unification of customers, employees and company values.
From trust to tacit understanding to seek excellence through collaboration
The plant of Prometheus Bio Inc was granted ISO13485:2016 certification. In 2012 and 2016, the production of Prometheus Bio Inc facility was inspected by US FDA and no 483 form was issued.
The plant quality management system is subject to Chinese IVDs detailed implementation standards and inspected by NMPA in September 2008.
This standard is an effective solution to meet the comprehensive requirements of QMS. Manufacturers need to fulfill the requirements of medical device regulations and make commitments to product safety and quality, and adopting ISO 13485 is a practical and effective foundation for meeting these requirements.
Prometheus Bio Inc. Established in Year 2005. It is a company that integrates research and development, sales, and production. Dedicated to in vitro diagnostic products. Also in this year, CPC Facility Passed the ISO9001 Inspection.
Our CPC Facility Passed the First NMPA Inspection. Confirmed our company's professionalism and product quality, representing our compliance with NMPA requirements. NMPA is responsible for maintaining the certification results of certified enterprises to ensure the safety and reliability of products. Through NMPA, the legitimate rights and interests of consumers can be better protected. NMPA is the guarantee of product safety.
New Facility for Diagnostic Department Established. Owns high quality technical development, marketing &service team and also Strict Quality Control. As a result, our company is continuously reducing the cost of products, meanwhile improving the quality of products.
Whole Group Passed FDA Inspection without 483. Continuously improving standard operating procedures, controlling and tracking all aspects of product development, raw material procurement, warehousing, production, inspection, equipment maintenance, sales, and after-sales service, effectively ensuring product quality and ensuring the smooth operation of the company's quality management system.
Launch new products drug test cup reader and accelerate the market expansion speed of OUS (out of US) markets. The company's products are best-selling in countries such as the United States, Europe, Australia, New Zealand, and enjoy a reputation as a "trustworthy diagnostic product supplier" in the global market. At the same time, Prometheus is constantly accelerating its development and rooting in the domestic market.
Another FDA Inspection without 483. Continuously improving standard operating procedures, controlling and tracking all aspects of product development, raw material procurement, warehousing, production, inspection, equipment maintenance, sales, and after-sales service, effectively ensuring product quality and ensuring the smooth operation of the company's quality management system.