Precision Biologic Inc

Precision Biologic Inc specializes in in vitro diagnostic (IVD) reagents and kits used for coagulation testing. Their products include chromogenic assays for clotting factors like Factor VIII and Factor IX, plasma-based controls, and kits for detecting Factor VIII inhibitors. These devices are designed to help laboratories monitor hemophilia treatment and diagnose coagulation disorders, such as activated protein C resistance (APCR).

Precision Biologic Inc is based in Canada. Since their devices are intended for global use, they must comply with both Canadian and international regulatory standards. Their products are listed in the EU’s EUDAMED database and the FDA’s 510(k) registry, indicating they meet the requirements for Class II (IVD General) devices in those markets. Compliance ensures their reagents and kits are safe, effective, and suitable for clinical laboratory use.

Precision Biologic Inc’s devices are listed in the EU’s EUDAMED database and the FDA’s 510(k) registry. These registries are critical because they demonstrate that the company’s products have undergone the necessary regulatory evaluations to confirm their safety, performance, and compliance with applicable standards. Listing in these databases also helps healthcare professionals, laboratories, and regulators verify the legitimacy and authorized status of the devices before use.

Precision Biologic Inc’s devices fall under Class II (IVD General) classification. This classification is assigned based on the risk associated with the device’s use—Class II devices pose moderate risks and require specific regulatory controls to ensure their safety and effectiveness. Since coagulation testing reagents and kits can influence patient diagnosis and treatment, they must meet stringent performance and validation criteria before authorization.