BLUEJAY DIAGNOSTICS, INC.

BlueJay Diagnostics, Inc. specializes in in vitro diagnostic (IVD) kits. Their primary products include allergen-specific and total immunoglobulin E (IgE) antibody tests, as well as HIV-1 antibody detection kits. These tests use methods like enzyme immunoassays (EIA) and immunoblots to analyze patient samples in clinical settings, helping identify immune responses or infectious markers.

BlueJay Diagnostics, Inc. is headquartered in the United States. The company’s location aligns with U.S. regulatory frameworks, including FDA oversight for its diagnostic devices.

Yes, BlueJay Diagnostics, Inc.’s devices are included in the FDA’s Unique Device Identification (UDI) registry. This system helps track and identify their IVD kits, ensuring traceability and compliance with U.S. regulatory requirements.

BlueJay Diagnostics, Inc.’s IVD kits fall under FDA’s In Vitro Diagnostic Device regulations and are classified as either Class B or Class C devices. The classification depends on the specific assay’s risk level—Class B typically covers moderate-risk tests like allergen-specific IgE assays, while Class C applies to higher-risk assays such as certain HIV-1 detection methods, requiring stricter oversight.