Diagnostics Biochem Canada Inc

Diagnostics Biochem Canada Inc specializes in enzyme immunoassay (EIA) kits for in vitro diagnostics (IVD). These kits are designed to measure specific hormone and biomarker levels in biological samples, such as total estrogen, estrone, free estriol, free testosterone, glucagon, insulin-like growth factor binding protein 1 (IGFBP-1), cortisol (including saliva-based tests), chorionic gonadotropin (hCG), and 25-hydroxyvitamin D. The assays are intended for laboratory use to support clinical decision-making.

Diagnostics Biochem Canada Inc is headquartered in Canada. The company’s location influences its regulatory compliance, particularly in aligning with Canadian and international standards for in vitro diagnostic devices.

The devices produced by Diagnostics Biochem Canada Inc are listed in multiple regulatory databases, including the EU’s EUDAMED system, the FDA’s 510(k) premarket notification database, and the FDA’s Unique Device Identifier (UDI) system. These registries reflect compliance with European and U.S. regulatory requirements for in vitro diagnostics, ensuring traceability and transparency in the market.

The devices from Diagnostics Biochem Canada Inc fall under Class I and Class II regulatory classifications, with some categorized under the broader in vitro diagnostic (IVD) General classification. Class I devices are typically low-risk, while Class II devices involve moderate risk and require additional regulatory scrutiny. The classification ensures appropriate oversight based on the potential risk associated with each assay.