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Certifications & Accreditations

We have been certified by leading organizations to affirm the quality and reliability of our medical testing and research services.

Office of the Board of Investment (BOI)

Promoted Business Category:

Provision of medical testing services utilizing biotechnology (Category 7.12.6)

  1. Preparation of test results and/or synthesis of biological substances
  2. Quality assurance and control
  3. Verification of medical diagnostic accuracy
  4. Capability to expand testing services to handle up to 294,000 samples annually

Thailand Center of Excellence for Life Sciences (TCELS)  

Confirmation of the enterprise’s eligibility under Category 7.12.6 – Biotechnology

Details of business activities in medical biotechnology:

  1. Genetic analysis through DNA sequencing
  2. Research and development of GeneChip technology (DNA Microarray)
  3. Personalized medicine diagnostics and analysis

Certificate of Registration – ISO 9001:2015

มาตรฐานที่ได้รับรอง

ISO 9001:2015 – ระบบบริหารคุณภาพ (Quality Management System)


Accredited Laboratory Certificate – ISO 15189:2022

มาตรฐานที่ได้รับรอง

ISO 15189:2022 – ความสามารถเฉพาะด้านของห้องปฏิบัติการทางการแพทย์

(Medical laboratories – Requirements for quality and competence)


Certificate of Accreditation – ISO 15190:2020

มาตรฐานที่ได้รับรอง

ISO 15190:2020 – มาตรฐานด้านความปลอดภัยในห้องปฏิบัติการทางการแพทย์

(Medical laboratories – Requirements for safety)



Certificate of Laboratory Competency

for SARS-CoV-2 Detection by Real-time RT-PCR Method

Testing methodology includes:

Real-time RT-PCR

  1. Individual nasopharyngeal and throat swab sample
  2. Pooled nasopharyngeal and throat swab samples

Certificate of Laboratory Competency

for HPV Screening by HPV DNA Testing

Testing Method:

HPV DNA testing

Detection using reagents for 14 high-risk types of Human Papillomavirus (HPV)

Certificate of Technical Evaluation  

Issued to:

Kunming Biochip Biotechnology Co., Ltd.

A certified medical laboratory


Laboratory Type:

Clinical PCR Laboratory for genetic material amplification



Yunnan Provincial Science and Technology Award Certificate 

Issued to:

Kunming Biochip Biotechnology Co., Ltd.


Award Type:

Scientific and Technological Progress Award



Certificate of Medical Device Registration  

Issued to:

Kunming Biochip Biotechnology Co., Ltd.

A registered manufacturer


Certified Product:

HPV diagnostic test kit utilizing Polymerase Chain Reaction (PCR) method


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Computer Software Copyright Certificates

Issued to:

Kunming Biochip Biotechnology Co., Ltd.


Certified Product:

  • Gene Analysis Software System
  • DNA Test Result Management System
  • Automated Pathogen Detection System
  • Genetic Data Analysis System
  • ​Software Platforms for Medical and Biotechnology Applications

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High and New Technology Enterprise Certificate

Issued to:

Kunming Biochip Biotechnology Co., Ltd.


Details:

Certified as a “High and New Technology Enterprise” under the criteria of the Chinese government, reflecting the company’s strong capabilities in innovation, research and development, and the application of advanced biotechnology in its operations.

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Specialized and Innovative Small and Medium-sized Enterprise (SME) Certificate

Issued to:

Kunming Biochip Biotechnology Co., Ltd.


Details:

Recognized as a “Specialized, Refined, Differential, Innovative” (SRDI) SME, demonstrating the company’s excellence in innovation, technological capability, and specialized expertise in the biotech industry.

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Medical Device Manufacturing License

HPV Testing using HPV DNA Testing Method  

Issued to:

Kunming Biochip Biotechnology Co., Ltd.


Scope of Manufacturing:

Class III Medical Devices – Registration Code: 6840

In Vitro Diagnostic Test Kits (In Vitro Diagnostic Reagents - IVD)

which includes:

  • PCR Test Kits
  • HPV Test Kits
  • Infectious Disease Test Kits such as COVID-19, HIV, HPV, etc.



External Quality Assessment (EQA) Certificate  

Issued to:

Kunming Biochip Biotechnology Co., Ltd.


Details:

The laboratory has successfully passed the national External Quality Assessment (EQA) for the year 2024 in the category of Nucleic Acid Detection for Non-viral Pathogens, with results rated as "Qualified".

  • Mycobacterium tuberculosis DNA (TB DNA)
  • Chlamydia trachomatis DNA (CT DNA)
  • Neisseria gonorrhoeae DNA (NG DNA)

External Quality Assessment (EQA) Certificate  

Issued to:

Kunming Biochip Biotechnology Co., Ltd.


Details:

Successfully passed the national-level laboratory quality assessment

  • for HPV (Human Papillomavirus) genetic analysis,
  • meeting official performance standards.

External Quality Assessment (EQA) Certificate  

for Viral Nucleic Acid Testing

Issued to:

Kunming Biochip Biotechnology Co., Ltd.


Details:

Successfully passed the national-level laboratory quality assessment

  • Quantitative HBV DNA testing
  • Quantitative HCV RNA testing

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