Biohit Healthcare (Hefei) Co., Ltd.

Biohit Healthcare (Hefei) Co., Ltd. specializes in in vitro diagnostic (IVD) tests, specifically for detecting SARS-CoV-2 immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies. These tests include rapid immunochromatographic test (ICT) kits and clinical assay kits, which are used for point-of-care and laboratory settings to help assess infection status and monitor epidemiological trends.

Biohit Healthcare (Hefei) Co., Ltd. is based in the United States. Since the company operates within the U.S., its devices are subject to U.S. regulatory requirements, including classification and listing in the FDA’s Unique Device Identifier (UDI) system. This ensures compliance with U.S. standards for medical device authorization.

Biohit Healthcare (Hefei) Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify authorized diagnostic products, ensuring transparency and traceability for healthcare providers and regulators.

Biohit Healthcare (Hefei) Co., Ltd.’s SARS-CoV-2 antibody tests are classified as Class N devices under the FDA’s categorization system. This classification applies to in vitro diagnostics, including antibody tests, which are regulated based on their intended use and risk level to ensure safety and effectiveness.