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Quality
 

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.

Quality milestone:

l   Nov, 2005, Quality system establishment.

l   Feb, 2006, achieved TUV ISO134852003 certificate.

l   Registered in the US FDA as a medical device establishment.

l   Jan, 2010, got EC-Certificate List B and Self.

l   August, 2010, got G-MED EC certificate HIV.

 l   June, 2011, got ITC EC certificate HBV & HCV.

Accreditations

 l   Registered with the U. S. FDA as a medical device establishment

 l   ISO 13485:2003

 l   Japanese jGMP certifications as an IVD device manufacturing establishment

 l   Registered with regulatory agencies of Canada as a qualified medical device manufacturer

 l   Registered with regulatory agencies of Australia as a qualified medical device manufacturer

 l   Registered with regulatory agencies of Brazil ANVISA as a qualified IVDD manufacturer

 l   Most of the products are CE-marked

A no. of products match US FDA 510(k) requirements

 
DO YOUR BEST
Drug Manufacturing Certificate
 

ABON ISO13485 Certificate


ITC EC certificate HBV & HCV

G-MED EC certificate HIV

EC-Certificate List B and Self

 

   
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