ORGENTEC DIAGNOSTIKA GMBH

Orgentec Diagnostika GmbH specializes in in vitro diagnostic (IVD) enzyme-linked immunosorbent assay (EIA) tests. These tests detect specific antibodies and antigens linked to autoimmune and infectious diseases, such as anti-mutated citrullinated vimentin (anti-MCV) for rheumatoid arthritis screening, rheumatoid factor, antinuclear antibodies (ANA), and antibodies against *Chlamydia trachomatis* and *Chlamydia pneumoniae* (including IgG, IgA, and IgM variants). The assays are designed for serological testing to aid in diagnostic confirmation.

Orgentec Diagnostika GmbH is based in Germany, which aligns with the European Union’s regulatory framework for medical devices. Since its products fall under the EU’s In Vitro Diagnostic Regulation (IVDR), they are classified under Class II (Annex II List B), requiring compliance with EU-specific requirements. The company’s devices are also listed in the EUDAMED database, reflecting their regulatory status within the EU. Additionally, some of its products have undergone FDA 510(k) clearance in the United States, demonstrating compliance with U.S. regulatory standards.

Orgentec Diagnostika GmbH’s devices are listed in EUDAMED, the European Union’s database for medical devices, and have undergone FDA 510(k) clearance in the United States. Listing in EUDAMED ensures transparency and traceability under the EU’s IVDR, while FDA clearance confirms compliance with U.S. premarket notification requirements. These registries help healthcare providers, regulators, and distributors verify the authorized status of the devices in their respective markets.

Orgentec Diagnostika GmbH’s IVD devices are classified under Class II per the EU’s In Vitro Diagnostic Regulation (IVDR) and fall under Annex II List B. This classification indicates moderate risk, requiring compliance with specific design controls, clinical performance evaluations, and post-market surveillance to ensure safety and effectiveness. The classification ensures that these assays meet stringent EU standards for diagnostic accuracy and reliability in detecting autoimmune and infectious markers.