Genes 2Me Private Limited

Genes 2Me Private Limited specializes in molecular diagnostics, producing real-time PCR kits for detecting specific genetic mutations and infectious agents like EGFR mutations, syphilis, gastrointestinal pathogens, and West Nile virus. They also develop next-generation sequencing (NGS) panels for applications such as lymphoid leukemia detection, HLA typing, and clinical exome sequencing. Additionally, the company offers a rapid antibody test for syphilis and a library preparation kit designed for NGS workflows. These products are primarily focused on genetic and pathogen detection.

Genes 2Me Private Limited is headquartered in India. The company’s manufacturing and development activities are conducted from this location, supporting its global distribution of diagnostic solutions.

Genes 2Me Private Limited’s devices are registered in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry tracks information about manufacturers, authorized representatives, and devices placed on the EU market, ensuring transparency and compliance with regulatory requirements.

Genes 2Me Private Limited’s devices fall under Class A and In Vitro Diagnostic (IVD) General classifications. Class A devices are typically considered low-risk, while IVD General classifications apply to diagnostic tests that detect or measure substances in the human body, such as genetic markers or pathogens. These classifications help determine regulatory pathways and compliance requirements for each product.