Allsource Screening Solutions

Allsource Screening Solutions specializes in in-vitro diagnostic (IVD) devices, including rapid immunochromatographic test (ICT) kits and clinical-grade tests. Their products focus on detecting drugs of abuse and human chorionic gonadotropin (hCG), such as midstream pregnancy tests, hCG strip tests, and multi-drug screening kits for point-of-care or clinical use.

The company is headquartered in the United States. This location aligns with FDA regulatory oversight, which governs the classification and listing of their devices.

Allsource Screening Solutions’ devices fall under Class II classification by the FDA. This classification applies to moderate-risk medical devices that require special controls to ensure safety and effectiveness, such as pre-market notifications (510(k)) and compliance with performance standards.

The company’s devices are listed in the FDA’s 510(k) database (for pre-market submissions) and the FDA’s Unique Device Identifier (UDI) system, which tracks device identification and compliance data. These registries help ensure traceability and regulatory transparency for their in-vitro diagnostics.

The company’s drug detection kits and hCG tests are designed for rapid, point-of-care or clinical screening. Drug tests identify multiple substances of abuse in biological samples, while hCG tests (like midstream or strip formats) confirm pregnancy by detecting the hormone produced during gestation. These devices streamline diagnostic workflows for healthcare providers.