ACON Laboratories, Inc.

ACON Laboratories, Inc. is a US FDA-registered global medical device manufacturer specializing in point-of-care testing (POCT) and immunoassay products. Headquartered in San Diego, California, the company develops and manufactures diagnostic solutions across four primary product lines: Point of Care, Immunoassays, Molecular Diagnostics, and Animal Health. Products serve hospitals, clinical laboratories, physician offices, blood banks, pharmacies, and veterinary clinics worldwide. The On Call® Blood Glucose Meter Family is designed for glucose monitoring and diabetes management. Mission® brand includes urine reagent test strips, urine analyzers, and handheld devices for cholesterol, coagulation, and hemoglobin measurement. HealthyMe® provides urinary tract infection (UTI) detection reagent strips. Flow flex® is the newest lateral flow rapid testing brand, offering multiplexed home tests including the recently FDA 510(k)-cleared Flow flex® Plus RSV + Flu A/B + COVID multiplex rapid antigen test for ages 6 months and up. The company's ACON brand offers lateral flow rapid tests for pregnancy, cancer markers, and infectious disease screening, including SARS-CoV-2 antibody and antigen tests. Distinct® provides pregnancy rapid tests using qualitative chromatographic immunoassays. Foresight® offers allergen immunoblot testing for 30 allergens on a single strip. Promotor® provides nucleic acid extraction systems and PCR quantitative test kits for HBV, HCV, HPV 16/18, HPV genotyping, tuberculosis, and HLA-B27. CentriVet® serves veterinary diagnostics with dual ketone/glucose meters and urine reagent strips. ACON maintains US FDA registration, provides contract manufacturing and OEM services, and holds multiple FDA 510(k) clearances for its diagnostic products.