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SD Biosensor shares the company news, including product development and global business activities, through the newsroom board.

NEWS

  1. FDA issues an EUA for STANDARD M nCoV Real-Time Detection Kit.

    US FDA gives EUA (Emergency Use Authorization) to STANDARD M nCoV Real-Time Detection Kit made by SD BIOSENSOR in 23 April, 2020. STANDARD M nCoV Real-Time Detection Kit, which is approved by US FDA EUA, is used for rapid identification and detection of novel coronavirus (2019-nCoV) nucleic acids in human nasopharyngeal swabs and throat swab samples. This is RT-PCR test that amplifies and diagnoses a specific gene sequence of COVID-19. With this approval, SD BIOSENSOR has the authority to supply...
    Date2020.04.24 CategoryNEWS Views3818
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  2. US FEMA to receive 300,000 coronavirus tests from SD BIOSENSOR.

    CNN, one of global broadcasting systems in United States, reported that FEMA (Federal Emergency Management Agency) awarded a contract to SD BIOSENSOR last week to provide coronavirus test kits. Please find attached articles. (EN) https://edition.cnn.com/2020/04/13/politics/south-korea-coronavirus-tests/index.html (KR) https://n.news.naver.com/article/081/0003082485?lfrom=kakao
    Date2020.04.14 CategoryNEWS Views1532
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  3. Now, we open the official SNS page, please follow us!

    You can visit us directly like below: Facebook : https://www.facebook.com/SDBIOSENSOR.pr Instagram : https://www.instagram.com/sdbiosensor_pr/ Twitter : https://twitter.com/SDBIOSENSOR_PR Youtube : https://www.youtube.com/channel/UC5z_5F9oGoPG89ZOp7N9SWg?view_as=subscriber
    Date2020.04.03 CategoryNOTICE Views842
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  4. [British Headline] COVID-19 Antibody Test is a Potential Game Changer!

    Public attention for Covid-19 antibody kit developed by SD BIOSENSOR is increasing rapidly. Under this circumstances, the U.K government Cheif Scientific Advisor, Patrick Vallance, has descirbed COVID-19 antibody test as a potential "game changer", and it would be "transformational" said Chris Whitty, the Chief Medical Advisor. The following articles will help you understand why the British government is so serious about using COVID-19 antibody tests to control this pandemic disaster. https://ww...
    Date2020.03.20 CategoryNEWS Views2495
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  5. Supporting the World Fight Against COVID-19

    SD BIOSENSOR has developed four different diagnostic kits for the detection of novel coronavirus(COVID-19). STANDARD M nCOV Real-Time Detection kit has been approved by South Korea EUA since Feburary 2020, and is already playing an important role as a confirmation method for COVID-19 in Korean domestic market. Due to the fact that WHO currently declared COVID-19 outbreak a pandemic, the needs for rapid screening kits are newly emerging. In keeping with this trend, we expects our STANDARD Q and S...
    Date2020.03.19 CategoryNEWS Views3386
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  6. Introducing SD BIOSENSOR’s WHO Prequalified RDT Line-up

    STANDARD Q HCV Ab Test, STANDARD Q Malaria P.f Ag Test, STANDARD Q Malaria P.f/P.v Ag Test, and STANDARD Q Malaria P.f/Pan Ag Test have been listed on the World Health Organization’s prequalification project. Please find the public reports and performance data through the official website of the World Health Organization. https://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/ If you have any further inquiry, please feel free to contact our sales representatives or via email(sal...
    Date2020.03.19 CategoryNEWS Views1700
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  7. MEDICA 2019

    GLOBAL NEWS Expanded Product Lines in 2019 MEDICA! ==================================================================== SD Biosensor participated in the MEDICA from November 18th to 21st. With expanded product lines, SD Biosensor exhibited with a larger booth size this year. Visitors showed a large interest in the new products, and especially to the STANDARD M, which is the Point-of-care MDx platform. STANDARD M can test both quantitative and qualitative parameters, and 7 tests are available now,...
    Date2019.12.03 CategoryEVENT Views517
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  8. Expert Review Panel for Diagnostics approval expands access to a G6PD deficiency test that supports P. vivax malaria treatment and elimination initiatives

    The STANDARD™ G6PD has achieved provisional Expert Review Panel for Diagnostics (ERPD) approval, which enables procurement with Global Fund and Unitaid funds. Point-of-care diagnostics for G6PD deficiency play a critical role in supporting appropriate treatment of Plasmodium vivax malaria and efforts to eliminate the disease. Up to 2.85 billion people may be at risk of infection with Plasmodium vivax malaria. It is the most difficult type of malaria to fully treat because a form of the mal...
    Date2019.10.08 CategoryNEWS Views1304
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  9. CE-IVD Certification of STANDARD™ Q HCV Ab

    SD BIOSENSOR receives CE-IVD mark for STANDARD™ Q HCV Ab Test. It is SD BIOSENSOR’s 1st 'List A' test, in compliance with the in vitro Diagnostic Directive (IVDD) 98/79/EC. STANDARD™ Q HCV Ab Test qualitatively analyzes antibodies specific to hepatitis C virus in serum and plasma using immunochromatography. With a simple test method, the screening test result can be obtained within 5 minutes with outstanding sensitivity and specificity. Diagnostic Sensitivity : 100.0% (4...
    Date2019.09.11 CategoryNEWS Views483
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  10. Global Fund ‘ERPD’ Authorization: STANDARD™ Q HIV/Syphilis Combo, Q Syphilis Ab

    The Global Fund concluded that our STANDARD™ Q HIV/Syphilis Combo and Q Syphilis Ab are eligible for procurement with Global Fund and/or UNITAID resources until 25 August 2020. We are working on WHO PQ approval of STANDARD™ Q HIV/Syphilis Combo Test. The expected approval is around Q1 2020 which means the procurement will be continued beyond August 2020. The product was evaluated successfully in Belgium, Germany, Congo, Peru, and more evaluations are ongoing in Ghana and India. [Publi...
    Date2019.08.30 CategoryNEWS Views745
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