ERBA Diagnostics, Inc., through its subsidiaries, develops, manufactures, and markets diagnostic test kits, or assays, and automated systems that are used to aid in the detection of disease markers primarily in the areas of autoimmune, infectious diseases, clinical chemistry, hematology, and diabetes testing. The company is a subsidiary of ERBA Diagnostics Mannheim GmbH. The company’s subsidiaries include Delta Biologicals, S.r.l. (Delta); Diamedix Corporation; Drew Scientific, Inc.; ImmunoVision, Inc.; and JAS Diagnostics, Inc. The company’s tests are designed to aid in the identification of the causes of illness and disease, assist physicians in selecting appropriate patient treatment. Its tests are based on various technologies, including Enzyme Linked ImmunoSorbent Assay (ELISA) technology, clinical chemistry, hematology, and cell separation, as well as HPLC separations, all of which are clinical testing methodologies used worldwide. The company’s kits are designed to be performed either manually or in an automated format. In addition to its line of diagnostic kits, the company designs and manufactures laboratory instruments that perform the tests and provides results. Its existing proprietary instruments, named the Mago 4, Mago 4S, Mago Plus, and Aptus systems, include an automated ELISA processor operating with its own software, which allows customers to perform tests in an automated mode. The company updated the Mago Plus instrument to include the capability to process ELISA and ImmunoFluorescent Assay (IFA) simultaneously. It also delivers an upgraded version of the Mago Plus instrument, named the Mago 4, which performs both ELISA and IFA techniques simultaneously, performs positive sample identification, and utilizes disposable pipette tips. The Mago 4 offers an improved automation solution to customers who prefer a lower-priced instrument. The company also continued the development of a variation of the Mago Plus, named the Mago 4S, for the market in the United States. The Mago 4S also performs both ELISA and IFA techniques simultaneously. The company received the required 510(k) regulatory clearance for the Mago 4S and markets the instrument in the United States. The company also develops, manufactures, and markets raw materials, such as antigens used in the production of diagnostic kits. Sales and Marketing The company markets its products in the United States primarily through its own sales force to hospitals, reference laboratories, clinical laboratories, and research laboratories, as well as to other commercial companies that manufacture diagnostic products. It distributes its products in the United States through certain independent distributors. The company also sells some of its products to pharmaceutical and biotechnology companies. The company markets its products in certain international markets through a network of independent distributors. It markets and sells its products in Italy through Delta’s sales representatives and independent agents, who are restricted from selling competing products. The company also sells its products in other global markets through various independent distributors. Its marketing and technical service departments located in Miami Lakes, Florida, Springdale, Arkansas, and Pomezia, Italy support their efforts. The products that the company markets in the United States are purchased principally by healthcare providers that bill third party payors, such as governmental programs (Medicare and Medicaid), private insurance plans, and managed care plans, for healthcare services provided to their patients. In Italy and various other countries in Western Europe, the company’s products are sold primarily to public hospital laboratories, which are managed by government structures, either directly or indirectly. Research and Development The company incurred $840,000 for research and development activities in 2013. Its research and development efforts have been targeted primarily towards the development of the next-generation instrument — LISA XL. Governmental Regulation The testing, manufacturing, and selling of the company’s products are subject to regulation by various governmental authorities, principally the United States Food and Drug Administration. Competition The company’s competitors include Bio-Rad Laboratories, DiaSorin, INOVA, Alere, Meridian Bioscience, The Binding Site, and others. History ERBA Diagnostics, Inc. was founded in 1980.
erba diagnostics inc (ERB:NYSE Amex)
14100 NW 57th Court
Miami Lakes, FL 33014
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