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About Firstep

Firstep Bioresearch, Inc. is one of the leading manufacturers of in-vitro diagnostic (IVD) test kits in Taiwan. Its products include Drug screen test, Fertility testMyocardial marker test, Cancer screening test, Pathogen detection test (Helicobacter pylori, Dengue, Influenza A and B, COVID-19 etc.), Veterinary test and Immunoassay analyzer, which are suitable for medical (home use/professional use) and forensic purposes.

With advanced laboratory, facility and highly qualified staff, Firstep is a professional manufacturer authorized by BD (Becton, Dickinson and Company) in 2002. It is ISO13485 certified and has obtained several QMS certifications and sales licenses from TFDA.

In view of immense impact of drug abuse on people's health, Firstep has been engaged in R&D and manufacturing of drug abuse screening products. With tens of drug testing parameters, Firstep is the largest drug test manufacturer in Taiwan and has supplied drug screening tests to relevant government units for many years.

With years of experience in Rapid Test and IVD kit manufacturing, Firstep has become a dominant provider of contract manufacturing services (OEM/ODM) for the in vitro diagnostic products in Taiwan. It offers high-quality reagents and medical devices using Lateral Flow Immunochromatographic Technique and develops various categories of Antigen and Antibody Rapid Tests.

Firstep Bioresearch, Inc. constantly pursues innovative technology and cooperates with Taiwan's renowned universities of engineering science. In 2016, Firstep Bioresearch, Inc.  has successfully developed a micro-analysis reader, and enters officially the Point of Care Testing (POCT) field. Firstep Bioresearch, Inc. is one of the few manufacturers in Taiwan which possesses core technology of biotechnology, as well as optical engineering.


Our factory

Firstep Bioresearch, Inc. is located in Southern Taiwan Science Park, its factory includes a cleanroom of class 100,000 with complete automatic, semi-automatic manufacturing equipment and filling equipment for rapid test reagents. All products are manufactured according to TFDA QMS guidelines.