Hangzhou Clongene Biotech Co., Ltd.

Hangzhou Clongene Biotech Co., Ltd. specializes in in vitro diagnostic (IVD) devices. Their portfolio includes rapid immunoassay kits, chemiluminescent immunoassays, and point-of-care testing formats designed for detecting drugs of abuse, luteinizing hormone (LH), and human chorionic gonadotropin alpha-subunit. These devices are primarily used in clinical and non-clinical settings for rapid, point-of-care, or laboratory-based testing.

Hangzhou Clongene Biotech Co., Ltd. has a presence in the United States, though the company itself is based in Hangzhou, China. Their devices are developed and marketed globally, including in the US market.

Hangzhou Clongene Biotech Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their Class I and Class II devices, ensuring transparency in the regulatory and clinical environments.

Hangzhou Clongene Biotech Co., Ltd.’s devices fall into two regulatory classes: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices carry a higher risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.