BIOPIX DNA TECHNOLOGY P.C.

Biopix DNA Technology specializes in nucleic acid amplification devices and associated test kits. Their portfolio includes the PEBBLE qcLAMP Platform, a portable molecular diagnostics tool for rapid infectious disease detection, as well as single-use reagent kits like the COV19 qcLAMP kit (for COVID-19) and FluA qcLAMP kit (for influenza A virus). These products focus on point-of-care or near-patient testing for infectious pathogens.

Biopix DNA Technology is headquartered in Greece. Their devices are designed to comply with European Union regulatory requirements, specifically those governing in vitro diagnostic (IVD) devices. Since their products fall under Class A and IVD General classifications, they are subject to EU regulatory oversight, including mandatory listing in the EU’s eudamed database.

Biopix DNA Technology’s devices are listed in the eudamed database, which is the official EU registry for in vitro diagnostic (IVD) medical devices. This registration ensures transparency and compliance with EU regulatory requirements for IVD products, including traceability and market surveillance.

Biopix DNA Technology’s devices are classified under Class A (low-risk) and IVD General categories. Class A classification applies to devices with minimal risk to patients, while IVD General refers to in vitro diagnostics that do not fall into higher-risk classes (e.g., self-tests or high-complexity assays). This classification determines the regulatory pathway and compliance requirements for their market authorization.