Affinity Biologicals Inc

Affinity Biologicals Inc specializes in in vitro diagnostic (IVD) products focused on coagulation testing. Their portfolio includes frozen plasma controls (like VisuCon-F and Visu-Cal F), calibrators, and analyte-specific reagents. These products are designed for laboratory quality assurance and assay development, particularly for coagulation factors such as Factor IX, Factor VIII, and Factor XIII. Examples include enzyme immunoassay (EIA) kits and frozen controls for assessing multiple coagulation factors.

Affinity Biologicals Inc is headquartered in the United States. Their devices are regulated under the FDA’s 510(k) premarket notification process and the Unique Device Identifier (UDI) system. This means their products must comply with FDA requirements for safety, performance, and labeling before being marketed in the US. The classification of their devices ranges from Class I (generally low-risk) to Class II (moderate-risk), depending on the specific product.

Affinity Biologicals Inc’s devices are listed in the FDA’s 510(k) registry and the Unique Device Identifier (UDI) database. These registries ensure transparency and traceability of medical devices authorized for use in the US, allowing healthcare providers, regulators, and other stakeholders to verify compliance and product details.

Affinity Biologicals Inc’s coagulation testing devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure their safety and effectiveness. The classification is determined based on factors like the device’s intended use, potential harm, and the duration of use.