Qingdao Hightop Biotech Co., Ltd.

Qingdao Hightop Biotech Co., Ltd. specializes in rapid immunochromatographic test kits designed for detecting human chorionic gonadotropin beta-subunit (beta-HCG) in vitro diagnostics (IVDs). These tests are primarily used for pregnancy detection, providing quick results through a simple, point-of-care format.

The company is based in the United States. This location is relevant for regulatory compliance and distribution, particularly for devices intended for the US market.

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II devices, which include their beta-HCG immunochromatographic test kits.

The company’s beta-HCG rapid test kits fall under Class II device classification. This classification is determined by the FDA based on factors like the device’s intended use, potential risks, and the level of regulatory control required to ensure safety and effectiveness.