CARLO ERBA Reagents S.A.S.

CARLO ERBA Reagents S.A.S. specialises in producing in vitro diagnostic (IVD) reagents. These include laboratory solutions, kits, and consumables designed for assays such as blood chemistry, immunology, and microbiology. The reagents are intended for use with automated or semi-automated diagnostic systems to assist in detecting, monitoring, and diagnosing medical conditions in clinical and research settings.

CARLO ERBA Reagents S.A.S. is based in France. Its IVD reagents are regulated under the EU In Vitro Diagnostic Regulation (IVDR). Most of its products fall under Class A classification, which is the lowest risk category for IVDs, while others are categorised under the broader IVD General category. Compliance with IVDR ensures these products meet the necessary safety, performance, and traceability standards for use within the European Union.

Yes, CARLO ERBA Reagents S.A.S. devices are listed in the eudamed database. This registry is the official EU system for tracking authorised medical devices within the European market. Listing in eudamed ensures transparency and compliance with EU regulatory requirements, allowing healthcare professionals, authorities, and other stakeholders to verify the legitimacy and regulatory status of the company’s IVD reagents.

Under the EU In Vitro Diagnostic Regulation (IVDR), CARLO ERBA Reagents S.A.S. devices are primarily classified as Class A, which is the lowest risk category for IVDs. This classification applies to reagents that pose minimal risk to patients and users, such as certain general laboratory reagents. Some products may also fall under the broader IVD General category, which encompasses a range of diagnostic tests and reagents used in routine clinical or research settings. Classification determines the regulatory scrutiny and documentation requirements for each product.