Guava Technologies Enters International Clinical Market with ISO13485 Certification for Design and Manufacture of Medical Devices


HAYWARD, California, June 28 /PRNewswire/ --

- Understanding AIDS one cell at a time

Guava Technologies, Inc. today announced that it was successfully audited
to the requirements of ISO13485:2003 by BSI Management Systems. With this
certification, the company will redouble efforts on medical devices for the
international market, covering a variety of therapy areas, beginning with
HIV/AIDS.

"We are proud to receive this international recognition," said Lawrence
Bruder, President and CEO, Guava Technologies. "It's a clear indication of
our ability to consistently meet regulatory and customer requirements for
medical devices, and reflects our intense commitment to the highest possible
standards for design, development, manufacture, and service for all of our
products."

"ISO certification was the first step in our initiatives to deliver
quality medical devices to the global healthcare community," continued Mr.
Bruder. "We can now focus on international commercialization of our new CD4
T-cell System for monitoring treatment of HIV/AIDS. We designed the
system to be highly accessible to both developed and developing countries,
and hope it will prove useful in fighting the global AIDS pandemic."

"We have always been committed to stringent quality standards, and are
equally committed to having a positive impact on people's lives," said Todd
Christian, VP Commercial Operations, Guava Technologies. "By achieving ISO
certification, we can more fully leverage our patented technologies and
expertise to improve the health and well-being of people around the world,
beginning with the millions living with HIV."

ISO is a network of the national standards institutes of 157 countries,
and ISO 13485 is an internationally recognized standard to establish the
quality management systems applicable to manufacturers of medical devices. It
is harmonized to FDA 21 CFR part 820.

About Guava Technologies: Guava Technologies, Inc. 
(http://www.guavatechnologies.com) is a private biotechnology and medical
device company that designs, develops, and delivers easy-to-use, on-demand,
benchtop cell analysis systems. All systems provide absolute cell counts and
offer user-friendly, assay-specific analysis software to minimize time
between hypothesis and results/conclusion. Ideal for a broad range of medical
and biomedical applications, Guava(R) systems and reagents help scientists
around the world understand life one cell at a time.

Guava, the Guava Technologies Logo, and all other trademarks are the
property of Guava Technologies, Inc.

Web site: http://www.guavatechnologies.com

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