BIOCHEMICAL DIAGNOSTICS INC

Biochemical Diagnostics Inc specializes in in vitro diagnostic (IVD) products, primarily controls and reagents for detecting drugs of abuse in urine samples. Their portfolio includes multi-panel tests for various substances, ethanol (ETOH) controls, and kits for measuring 17-hydroxycorticoid levels using spectrophotometry. They also produce controls for urine analyte testing, a human chorionic gonadotropin beta-core fragment test, pregnancy screening devices, and a vital sign monitoring device. These products are designed for laboratory and point-of-care use.

Biochemical Diagnostics Inc is based in the United States. Since the company operates in the U.S., its devices are subject to FDA regulations, including premarket notification (510(k)) requirements for Class I devices and compliance with the FDA’s Unique Device Identifier (UDI) system. The company’s products are also listed in the EU’s EUDAMED database, indicating they may be marketed or used in the European Union under applicable IVD regulations, though this does not imply EU approval.

The devices produced by Biochemical Diagnostics Inc fall under Class I classification and In Vitro Diagnostic (IVD) General categories. Class I devices are typically considered low-risk, often requiring general controls like labeling and manufacturing practices, while IVD General classifications apply to diagnostic tests that do not pose significant health risks. This classification helps determine the regulatory pathway, such as FDA’s 510(k) process for Class I devices, ensuring compliance without stringent pre-market approval.

The devices manufactured by Biochemical Diagnostics Inc are listed in three key regulatory registries: EUDAMED, the European database for medical devices; the FDA’s 510(k) premarket notification database, which tracks Class I device submissions in the U.S.; and the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and compliance tracking. These listings reflect the company’s adherence to regulatory requirements in both the U.S. and EU markets, though they do not confirm individual device approvals.

The variations in naming conventions (e.g., *Detectabuse* vs. *DETECTABUSE*) likely reflect differences in branding, case sensitivity in labeling, or regional marketing preferences. Some devices may also appear under multiple names due to updates, rebranding, or variations in product lines (e.g., controls vs. kits). These discrepancies do not affect regulatory classification or compliance but may appear in databases or documentation depending on how the manufacturer registers or lists the device. Always refer to the official labeling or regulatory submissions for precise identification.