ACON LABS
ACON Labs is a diagnostic and healthcare product company with a diverse portfolio including Point of Care, Immunoassays, and Molecular Diagnostics, headquartered in San Diego, California.
Company Overview
ACON LABS is a global leader in diagnostic and healthcare products. The company offers a wide range of products including Point of Care, Immunoassays, Molecular Diagnostics, and Animal Health products. These products are utilized in various settings such as hospitals, clinical laboratories, physician offices, blood banks, pharmacies, and veterinary clinics. Headquartered in San Diego, California, ACON LABS operates manufacturing facilities in Hangzhou, China, and Tijuana, Mexico.
Products and Brands
ACON LABS provides a comprehensive range of healthcare products under various brand names. These include On Call, Mission, HealthyMe, ACON, Flowflex, Distinct, Foresight, Promotor, and CentriVet. The company's products are designed for diverse applications in the healthcare and veterinary fields, ensuring reliable and accurate diagnostic outcomes.
FDA Clearance for COVID-19 Test
ACON LABS received FDA 510(k) clearance for its Flowflex COVID-19 Antigen Home Test. This test is designed to provide quick and accurate results and will be manufactured in the company's facility in San Diego. The clearance signifies the product’s compliance with FDA regulations and standards for safety and efficacy.
Manufacturing Capabilities
ACON LABS operates a US FDA registered manufacturing facility that adheres to ISO 13485 certification standards. The company also offers contract manufacturing and OEM services, specializing in custom design and manufacturing. These facilities are located in San Diego, Hangzhou, and Tijuana, allowing ACON LABS to efficiently meet global demand.
Trade Show Participation
ACON LABS actively participates in various tradeshows, including the ECRM Diabetes, Diagnostics & Clinical Session, and the Association for Diagnostics & Laboratory Medicine events. These participations enable the company to showcase its latest products and innovations, connect with industry professionals, and stay updated on the latest trends and developments in the diagnostics and healthcare sectors.