Bioperfectus Acquired ISO 9001:2015 Certification

Company news

Shanghai, China, March 25th, 2022—As one of the leading in-vitro diagnostic manufacturers on infectious diseases globally, Bioperfectus solemnly announced that we acquired ISO 9001: 2015 Certification.


It is another recognition of our company quality management system in the international stage besides ISO 13485.”, said Bioperfectus International Sales & Marketing Division Deputy General Manager.


Bioperfectus has formerly obtained ISO 13485, which sets for medical devices company in the quality management system for regulatory purpose. The objective of ISO 9001 is to provide a set of requirements that, if effectively implemented, will give the endorsement of the company’s products and services:

  •  Meet customers’ needs and expectations
  •  Comply with applicable regulations



About ISO 9001: 2015 Certification

ISO 9001 is an International Standard that gives an organization’s quality management system (QMS) requirements. It is part of a family of standards published by the International Organization for Standardization (ISO) and often referred to collectively as theISO 9000 series” or “ISO 9000 family”. To learn more, please click here 

About Bioperfectus

Bioperfectus, a public listed company at Shanghai Stock Exchange (SSE:688399), has been one of the leading molecular diagnostic solution providers specialized in infectious diseases ever since 2010. With headquarters located in Jiangsu, subsidiaries in Shanghai, Beijing, Xi'an, Taizhou, Hainan, and Yinchuan. Bioperfectus is pioneering in the molecular diagnostics market with our products ranging from real-time PCR kits, nucleic acid extraction systems, rapid tests, and automation laboratory devices. Young and passionate, Bioperfectus people are working steadily and firmly to achieve our dream to create a healthier future for our next generations. 


Bioperfectus Supports Cholera Elimination

SHANGHAI, CHINA, December 5, 2022—Jiangsu Bioperfectus Technologies Co., Ltd. (hereinafter referred to as “Bioperfectus”) is pleased to launch Vibrio Cholerae Real Time PCR Kits for human diagnosis and early warning surveillance.


Client Story: A Race Against Time

Through a critical assessment of clinical evaluation and data validation, Bioperfetus successfully passed the Israeli ministry of health inspection. Bioperfetus was the only Chinese company on the procurement list and was asked to provide one million antigen rapid test kits for the Israeli ministry of health.


Bioperfectus Granted MDA Approval in Malaysia for Nucleic Acid Extraction Systems

SHANGHAI, CHINA, November 14, 2022—Jiangsu Bioperfectus Technologies Co., Ltd. (hereinafter referred to as “Bioperfectus”), a leading global company in the molecular diagnostics market, today announced receipt of MDA (Medical Device Authority) approval in Malaysia for Nucleic Acid Extraction Systems, including Nucleic Acid SSNP-2000B, SSNP-3000A, SSNP-9600A, SMPE-960 and Extraction Rapid Kit (Magnetic Bead Method).