ERBA Diagnostics Attains CE Mark for HB Vario A1c Detection System and Reagents for Management of Diabetes

Thursday, January 22, 2015

ERBA Diagnostics, Inc., has attained CE Mark clearance for the HB Vario A1c detection system and associated reagents. Monitoring A1c values can help healthcare providers manage complications from diabetes in patients.

The CE Mark registration provides marketing authorization in the 28 member states of the European Union and can be used for registration in additional countries who recognize the CE Mark. Following CE Mark clearance in December 2014, ERBA Diagnostics has commenced a limited launch of the HB Vario A1c detection system and associated reagents in Europe through its direct sales team and a limited launch in India through its distributor, and indirect parent company, Transasia Bio-Medicals.

"This clearance provides our customers with a valuable new product, which we will be able to commercialize through our existing global network of distributors and direct sales representatives," said Suresh Vazirani, Executive Chairman of ERBA Diagnostics. "The proprietary system and associated reagents are ideally suited for the underserved market of smaller hospitals, physicians clinics and reference labs who are looking for more cost-effective and accurate options. We are in the early launch phase and look forward to a broader release later this year."

The Hb-Vario is capable of processing up to 10 samples at a time with an assay time of just around 4 minutes per sample. The Hb-Vario can sample from a wide number of sample tubes. The touchscreen of the Hb-Vario, the interactive software and user-friendly features makes the unit extremely easy to use.

Diabetes continues to be one of the major challenges worldwide to the healthcare industry, a challenge that is pronounced in developing countries and emerging markets. It is currently estimated by the World Health Organization that 347 million people worldwide are afflicted with diabetes.


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