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



    
    Understanding AIDS one cell at a time
    

    HAYWARD, Calif., June 28 /CNW/ -- 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.





For further information:

For further information: Lisa English, Communications Director of Guava 
Technologies, Inc., +1-510-576-1394, lenglish@guavatechnologies.com Web Site:
http://www.guavatechnologies.com

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GUAVA TECHNOLOGIES, INC.

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