Sysmex America, Inc. Achieves Instrument FDA Clearance Milestone

MUNDELEIN, Ill., June 7 /PRNewswire/ -- Sysmex America, Inc. today announced that the Sysmex UF-1000iTM Automated Urinalysis Analyzer has been cleared by the United States Food and Drug Administration (FDA) for sale in the U.S., said John Kershaw, president, Sysmex America, Inc. The UF-1000i represents a new generation of particle analyzer for the clinical laboratory, classifying urine formed elements with minimal operator intervention, added Kershaw. This marks the company's newest urinalysis product launch in the U.S. since the debut of the company's UF-50 urinalysis analyzer in 2002 and paves the way for instrument upgrades for Sysmex's long-time urinalysis customers. "We will debut the UF-1000i at the AACC in July, and we expect to begin shipment later this summer," said Kershaw.

The UF-1000i provides high precision counts for white blood cells and red blood cells, improved sensitivity for pathological casts, and enhanced analysis information for the screening of patients with kidney disease. Reagents for the Sysmex UF-1000i are all new, allowing for improved discrimination of particles and potentially resulting in lower medical technologist review rates. This instrument also offers an improved bacteria detection mode, further enhancing patient screening. The product software is Windows(R) based and is easily navigated by medical technologists. Other product features include a smaller footprint, improved ergonomics, and a processing capability of 100 urine samples per hour. Like its predecessors, the UF-1000i automated analyzer uses laser-based, fluorescent urine flow cytometry for accurate and precise results.

"Sysmex is synonymous with workflow efficiency in the clinical laboratory by providing potential labor savings. The Sysmex UF-1000i offers true walk-away capability and frees laboratory technologists to concentrate on more complex tasks," said Carl Trippiedi, Senior Product Manager, U.S. Marketing, Sysmex America, Inc.

With the introduction of Sysmex's first fully automated urine cell analyzer in 1995, urinalysis has been transformed from a time-consuming and labor-intensive process to an unattended one.

About Sysmex America, Inc.

Sysmex America, Inc., the U.S. headquarters of Sysmex Corporation (Kobe, Japan), is a world leader in clinical laboratory systemization and solutions, including clinical diagnostics, automation and information systems. Serving customers for over 35 years, Sysmex focuses on extending the boundaries of diagnostic science while providing the management information tools that make a real difference in clinical and operational results for people worldwide. For more information about Sysmex, please visit http://www.sysmex.com/usa.

Sysmex America, Inc.

CONTACT: Tammy Kutz, Manager, Media & Events of Sysmex America, Inc.,+1-847-996-4531, kutzt@sysmex.com

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