Contract Manufacturing/OEM/ODM services

With years of experience in Rapid Test and IVD kit manufacturing, Firstep is a leading provider of contract manufacturing services (OEM/ODM) for the in vitro diagnostic products in Taiwan. Firstep offers high-quality reagents and medical devices using lateral flow immunochromatographic technique, and develops various categories of Antigen and Antibody Rapid Tests, such as

● Infectious Diseases (Pathogen Detection): COVID-19 (SARS-CoV-2) Test, Dengue Test, etc.

● Cardiac Markers: Troponin I (cTnI) Test, CK-MB Test

● Cancer Screening (Tumor Marker): Fecal Occult Blood Test (FOBT)

● Fertility Hormones: Pregnancy, Ovulation Test

● Drugs of Abuse Screen: Amphetamine, Marijuana/Cannabinoids, Morphine, Ketamine Test, etc.

We provide a full range of services, from initial product design, development, mass production, validation to subsequent regulatory support. Our experienced team monitors with rigorous attitude every detail during the development and production process to achieve the best results. Whether you need a customized or a standard product, we can meet your requirements and provide you the total solution within budget.

  

Why choose Firstep?

● We are deeply engaged in the Rapid Test industry for more than 20 years and have the most complete range of products in Taiwan.

● We have obtained several product manufacturing and sales licenses issued by the Ministry of Health and Welfare in Taiwan.

● Our plant has passed the QMS/GMP and ISO13485 certifications and complies with international standards.

● We are designated for contract manufacturing by many listed companies and renowned brands, our product quality is highly recognized.

● Our professional team with extensive experience can design, develop and optimize products according to your specifications and requirements and provide comprehensive technical support and product training.

● We produce, package the product and accessories with our state-of-the-art facility, advanced equipment and process technology in a timely and efficient manner.

● We can offer you regulatory support to speed up the registration and approval of your products in various markets and regions.

 

Services
Design and Development of Rapid Test	•        Determination of target analytes •        Selection of antibodies, antigens and chromogenic agents •        Membrane and pads engineering •        Optimization of reagent solutions •        Performance validation
Production of Rapid Test	•        Coating process (Membrane/Pads) •        Lamination process •        Device assembly (various housing types) •        Packaging (flexible kit formats)
Buffer filling (dispensing) (with foil sealing/cap locking)
Device housing engraving

Capabilities

● Advanced technologies and materials are adopted to create rapid tests with high accuracy, sensitivity and specificity.

● The manufacturing process and procedures follow strict quality control standards and comply with international regulations and certifications.

● With equipment and instruments applicable for large-scale production, our facility is capable to handle any volume of orders, from small batches to mass production.

● With a Class 100,000 clean room, the manufacturing process is conducted in an environment with controlled humidity and temperature to ensure product performance and stability.

● Product packaging and labeling can be customized according to customer's brand identity and preferences.

 

If you are interested in our products, please contact us freely.