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The quality policy is Rapid Test, Accurate Diagnosis,
Customer Focused, and Health Forever. Quality is everyone’s
responsibility in ABON. We promise to do the right thing right the
first time and continue to provide customers with reliable products
and services, realizing common values of customers, the company,
employees and partners. This policy is borne in minds by every staff
of ABON. It has been in mind that quality system is the life line of
the company, specially for ABON whose aim is to become the best and
the largest as well as the most efficient low cost and high quality
lateral flow immunoassay test producer for the world. During the
pursuit of the aim, we actively carry out staff training and
assessment at regular basis. Additionally, strict quality control
points are taken into practice during the whole manufacturing
process. We firmly believe that only achieving high product quality,
company can keep up the edge of the industry.
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Quality milestone:
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Nov, 2005, Quality system establishment.
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Feb, 2006, achieved TUV ISO13485:2003 certificate.
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Registered in the US FDA as a medical device
establishment.
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Jan, 2010, got EC-Certificate List B and Self.
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August, 2010, got G-MED EC certificate HIV.
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June, 2011, got ITC EC certificate HBV & HCV.
Accreditations
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Registered with the U. S. FDA as a medical device establishment
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ISO 13485:2003
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Japanese jGMP certifications as an IVD device manufacturing
establishment
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Registered with regulatory agencies of Canada as a qualified medical
device manufacturer
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Registered with regulatory agencies of Australia as a qualified
medical device manufacturer
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Registered with regulatory agencies of Brazil ANVISA as a qualified
IVDD manufacturer
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Most of the products are CE-marked
A no. of products
match US FDA 510(k) requirements
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