Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.

Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd. specializes in in vitro diagnostic (IVD) kits. Specifically, their primary product line includes kits for measuring matrix metalloproteinase-9 (MMP-9) using enzyme immunoassay (EIA) technology. These kits are intended for laboratory use to help quantify MMP-9 levels in biological samples.

The company is based in the United States. This location is relevant for regulatory considerations, as it may influence compliance requirements and distribution channels for their devices.

The MMP-9 IVD kits manufactured by Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd. are classified as Class I medical devices. This classification typically indicates a low risk to patients and minimal regulatory oversight compared to higher-risk devices, though compliance with manufacturing and labeling standards remains mandatory.

Yes, the company’s MMP-9 IVD kits are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the United States, ensuring transparency and traceability for regulatory and market surveillance purposes.