Getein SARS-CoV-2 Antigen Self-Test Certified by Thailand and Malaysia
09

/Dec 2021

Recently, One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) developed and manufactured by Getein Biotech, Inc. has been approved by MDA (Medical Device Authority Malaysia) and TFDA (Food and Drug Administration Thailand) respectively, and is approved to be marketed in both countries for self-testing of COVID-19 infection by the public. Currently, the self-test kits are widely available for purchase at pharmacies and medical institutions in both countries.


Certificate of Malaysia MDA




Certificate of Thailand FDA


Multiple countries Certified, Quality Management System Guaranteed

In addition to the certifications in Malaysia and Thailand, Getein One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) also received CE certification as early as July this year for its excellent clinical performance. By now, only 13 biotech companies in China have obtained the CE certification for their COVID-19 antigen self-test products. Besides, Getein One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) has also passed the PEI test in Germany and DHSC 3a verification in UK, and is listed on the import and export white lists of the EU and China.


Getein One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) is self-developed and produced by our self-owned factory using our self-produced raw materials, giving us superior quality control power over our product quality compared to other manufacturers in the industry. In addition, our ISO 13485 quality control system, which has been jointly audited by five countries, adds an extra layer of assurance of quality to our products.


Easy and Fast Testing

Getein One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) is very easy and fast to operate. No testing equipment is required. Individuals could perform the test by collecting nasal swabs themselves. The sampling process is simple and comfortable and the test results can be obtained in just 10-15 min.


The convenient operation allows this test to be widely used in many scenarios such as home, school, workplace, dormitory, cruise ship, airport, theater, etc.




Lately, Getein Biotech Inc. has improved the previous boxed single antigen test pack to a new soft pack design, saving significantly the shipping space and costs for our clients. The soft pack design comes with multiple languages on the package while keeping the exact same certifications as the boxed version, which allows its legal distribution in multiple markets.





A Comprehensive COVID-19 Test Solution Backed by Strong R&D Power

In order to respond to the global public health crisis, since the outbreak of the epidemic, Getein Biotech Inc. has organized its R&D team to quickly respond and launch a full range of nucleic acid + antigen + antibody + influenza differential test solutions to meet the needs of COVID-19 detection in different application scenarios, covering the full cycle of COVID-19 infection. At present, the company has more than ten COVID-19 testing products, all of which has obtained CE certifications as well as certifications in multiple overseas countries.


At this global difficult time, Getein Biotech Inc. continuously focuses the pandemic situation and contributes itself to the prevention and control of the COVID-19 pandemic, so as to promptly support the resumption of the global work & production as well as the early return of people’s normal life.


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