Bioteke 5 in 1 Test Kit Obtains EU IVDR CE 3018 Self-test Certification

Abstract

       On May 30, 2025, Bioteke Corporation(Wuxi) Co., Ltd, a well-known Chinese in vitro diagnostic reagent and medical device manufacturer, announced that its independently developed 5-in-1 respiratory antigen rapid test kit【commercial name “Multiple Respiratory Multipathogen Antigen Test Kit”】 successfully passed the EU IVDR regulation (In Vitro Diagnostic Medical Device Regulation) review and obtained CE 3018 self-test reagent certification. This means that the product not only meets the most stringent safety, effectiveness and traceability requirements of the EU market, but is also officially approved for sale in the EU market as a home self-testing product (self-testing device).

1. A breakthrough multiplex antigen testing solution

       The 5-in-1 rapid test kit uses immunochromatography and double antibody sandwich method to simultaneously detect five common respiratory virus antigens within 15 minutes, including:

• COVID-19 (SARS-CoV-2)

• Influenza A(Flu A)

• Influenza B(Flu B)

• Respiratory syncytial virus (RSV)

• Adenovirus (ADV)

Users only need to use a nasal swab to collect samples and add 3 drops of sample to obtain clear and readable test results. This product provides a rapid, autonomous and economical respiratory infection screening tool for families, schools, nursing homes, etc. around the world.

2. Comply with EU IVDR regulations to ensure safety and compliance

       Starting from 2022, IVDR Regulation (EU) 2017/746 will completely replace the old IVDD regulation, and put forward higher technical documentation, performance verification and post-market supervision requirements for in vitro diagnostic products. With its mature quality system (ISO 13485, ISO 9001) and compliance experience in product registration in multiple countries, Biotech successfully passed the technical review and clinical evaluation conducted by the EU Notified Body No. 3018 Certification Body and obtained the CE 3018 self-test certificate under the IVDR framework.

3. Global market expansion accelerates, B2B cooperation continues to open up

       Bioteke 5-in-1 rapid antigen test kit is available in multiple languages, including English, French, German, Polish, Spanish, and Italian, and is working with distributors, chain pharmacies, and medical institutions in Europe, Latin America, and Southeast Asia to distribute self-test products. The company provides OEM/ODM customization services, supports brand packaging, language instructions, and authorization registration support, helping partners quickly enter the local market.

4. About Bioteke

       Bioteke Corporation is a high-tech enterprise focusing on molecular diagnosis and rapid testing. Its products cover multiple fields including rapid antigen testing, fluorescent PCR testing, sample processing and automated laboratory equipment. It is committed to providing fast and reliable diagnostic solutions for global public health.

5. Global cooperation support

Medical device suppliers/wholesalers/agents need cooperation and technical support, please contact the Bioteke team.

BioTeke Corporation(Wuxi) Co., Ltd

E-mail: zr@bioteke.cn | International Market Depart.

Phone: +86-133-5792-7939

Whatsapp: +86-133-5792-7939

Website: www.bioteke.cn

Address: No.90 Huiming Rd, Huishan District, Wuxi 214174, China