ERBA Diagnostics, Inc. Receives 510(K) Clearance for the XL200 Clinical Chemistry Analyzer
ERBA Diagnostics, Inc. (NYSE MKT: ERB), a fully integrated in vitro diagnostics company, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) on the 510(k) premarket submission that ERBA Diagnostics had filed for its new clinical chemistry analyzer – the XL 200.
The XL-200 is a state-of-the-art, random access, clinical chemistry analyzer that can perform up to 400 tests per hour. Clinical chemistry analysis is one of the most widely and routinely performed diagnostics procedures in all clinical diagnostics laboratories.
Sanjiv Suri, Interim Chief Executive Officer of ERBA Diagnostics, said, “We are excited with this clearance as it enables us to provide a comprehensive clinical chemistry system with instrument and reagent kits for routine clinical chemistry and electrolytes. We expect the XL 200 to complement and enhance the existing portfolio of immunology and hematology systems we offer to U.S. hospitals, reference labs and physician office labs. We also expect the XL 200 to enhance our position with our key distributors to leverage their efforts and become more relevant to their customers with the enhanced offering.”
Mr. Suri continued, “Industry analysts estimate that the size of the U.S. clinical chemistry market is approximately $5.0 billion. We expect the XL 200 to give us an entry in to this significant market and contribute to our revenue growth in future. Industry analysts have stated that they expect a rise in the number of insured in the U.S. will likely be compounded with other factors to revive the IVD market.”
About ERBA Diagnostics, Inc.
ERBA Diagnostics, Inc. (, headquartered in Miami Lakes, Florida, is a fully integrated in vitro diagnostics company that develops, manufactures and distributes in the United States and internationally, proprietary diagnostic reagents, test kits and instrumentation, primarily for autoimmune and infectious diseases, clinical chemistry, hematology and diabetes through its six subsidiaries – Diamedix Corporation (U.S.), Delta Biologicals S.r.l. (Europe), ImmunoVision, Inc. (U.S.), Drew Scientific, Inc. (U.S.), JAS Diagnostics, Inc. (U.S.), and Erba Diagnostics Mexico S.A. (Latin America).
Safe Harbor Statement
Except for the historical matters contained herein, statements in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect the business and prospects of ERBA Diagnostics, Inc., including, without limitation, the risks and uncertainties related to: the ability of ERBA Diagnostics to commercially launch the XL 200 when expected, or at all; the impact of the anticipated timing of the commercial launch of the XL 200 on the judgments and estimates ERBA Diagnostics has made with respect to its financial condition, operating results and cash flows; ERBA Diagnostics’ ability to successfully market the XL 200; the ability of the XL 200 to perform as expected; the ability of the XL 200 to complement and enhance ERBA Diagnostics’ existing portfolio of instruments and reagent kits; the ability of the XL 200 to enhance ERBA Diagnostics’ position with its key distributors, whether by enabling them to leverage their efforts and become more relevant to their customers with enhanced offerings, or otherwise; the ability of the XL 200 to be a source of revenue growth for ERBA Diagnostics in the future; constantly changing, and ERBA Diagnostics’ compliance with, governmental regulation; ERBA Diagnostics’ ability to achieve cost advantages from its own manufacture of instrument systems, reagents and test kits; and economic, competitive, political, governmental and other factors affecting ERBA Diagnostics and its operations, markets and products. In addition to the risks and uncertainties set forth above, investors should consider the economic, competitive, governmental, technological and other risks and uncertainties discussed in ERBA Diagnostics’ filings with the Securities and Exchange Commission, including, without limitation, the risks and uncertainties discussed under the heading “Risk Factors” in such filings.

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