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Professional supplier of in vitro diagnostic reagents and services.

Professional supplier of in vitro diagnostic reagents and services.

Professional Supplier of In Vitro Diagnostic Products and Services

GenSure Biotech Inc.

GenSure Biotech Inc.,founded in Shanghai in 2014,is a high-tech company specializing in the R&D,manufacturing,and distribution of in vitro diagnostic(IVD) reagents and instruments.We offer rapid test kits for infectious diseases (respiratory,gastrointestinal,STIs,tropical disease),bacterial vaginitis and fertility hormones,as well as fluorescence immunoassay quantitative assays and multi-pathogen combo panels.Our products are CE-marked and globally sold.We also provide flexible OEM/ODM services.With automation,QC,and regulatory expertise,GenSure offers affordable,scalable diagnostic solutions.

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News

GenSure Biotech Secures CE IVDR Certification for Four At-Home Rapid Test Kits, Marking a New Chapter in Globalization Strategy

2025

08-22

GenSure Biotech Secures CE IVDR Certification for Four At-Home Rapid Test Kits, Marking a New Chapter in Globalization Strategy

[Beijing, China — Date] – GenSure Biotech Inc. today reached a significant milestone as four of its at-home rapid diagnostic test kits — Strep A, LH Ovulation, HCG Pregnancy, and Flu A+B — have simultaneously obtained EU CE IVDR certification. This achievement not only serves as solid proof of product excellence but also marks a critical step forward in the company’s globalization strategy.

2025

08-20

Good News! GenSure FOB-Fecal Occult Blood Rapid Test Approved by MOH Indonesia

2022

12-15

Statement

2022

11-02

GenSure to Attend Medica in Düsseldorf