LOUISVILLE APL DIAGNOSTICS, INC.

Louisville APL Diagnostics manufactures in vitro diagnostic kits for the detection of antiphospholipid (aPL) antibodies, used in the diagnosis of Antiphospholipid Syndrome (APS). The company's FDA-cleared product portfolio includes the APhL ELISA Kit and APL ELISA Kit for detection of IgG, IgM, and IgA aPL antibodies; the LAPL aβ₂GPI HRP ELISA Kit for detection of IgG, IgM, and IgA anti-beta-2 Glycoprotein I antibodies; and calibrators and positive controls for anticardiolipin and β₂Glycoprotein 1 (for research use). Products are ELISA-based immunoassay reagents designed for clinical laboratory use in the diagnosis of APS, a thrombophilic disorder. The company maintains quality assurance protocols and regulatory compliance with FDA oversight. Louisville APL Diagnostics serves clinical laboratories, hematology and thrombosis centers, and research institutions requiring specialized diagnostic testing for antiphospholipid-related disorders.