Axim Biotechnologies, Inc.

Axim Biotechnologies, Inc. specializes in in-vitro diagnostic (IVD) devices. Their primary products include allergen-specific immunoglobulin E (IgE) antibody tests, such as rapid immunoassay kits and self-testing formats. They also produce lactoferrin detection kits for clinical and rapid point-of-care use, as well as photometric/spectroscopic immunoassay analysers designed for laboratory settings. These devices are developed to assist in allergy testing, infection monitoring, and other diagnostic applications.

Axim Biotechnologies, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as its devices are subject to US regulatory requirements, including classification and listing in the FDA’s Unique Device Identifier (UDI) database.

Axim Biotechnologies’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the US, ensuring transparency and traceability in the healthcare system. Listing in this database is a requirement for Class I devices, which include most of Axim’s products.

Axim Biotechnologies’ devices fall under Class I regulatory classification in the US. This classification applies to low-risk devices that pose minimal potential harm to users. Class I devices typically require general controls (such as good manufacturing practices) but do not require pre-market approval or additional scrutiny beyond registration and listing in the FDA’s UDI database. The company’s focus on rapid diagnostic kits and immunoassays aligns with this classification due to their relatively low risk profile.