DEEPBLUE Medical Receives Malaysian Registration for Dengue NS1 & IgG/IgM Combo Test Kit

Jul 02, 2025

Hefei, China – July 2025 — Anhui DEEPBLUE Medical Technology Co., Ltd. is pleased to announce that its Dengue NS1 & IgG/IgM Combo Test Kit (Colloidal Gold) has officially received the Medical Device Registration Certificate from the Medical Device Authority (MDA) of Malaysia, under the Medical Device Act 2012 (Act 737), Section 5(1).


This certification confirms that the Dengue Combo Test Kit complies with Malaysian regulatory requirements and is officially approved for distribution and use in the Malaysian market. The test kit enables rapid and simultaneous detection of Dengue NS1 antigen and IgG/IgM antibodies, providing critical early diagnostic support for clinicians in managing dengue fever outbreaks.


The recognition by Malaysia's regulatory authority highlights DEEPBLUE Medical’s commitment to high-quality diagnostics and international regulatory compliance, further expanding its presence in Southeast Asia.


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About Dengue Virus


Dengue virus is a mosquito-borne virus primarily transmitted by Aedes aegypti mosquitoes. It belongs to the Flavivirus genus and has four distinct serotypes (DENV-1 to DENV-4). Dengue is commonly found in tropical and subtropical regions, with high prevalence in Southeast Asia, South Asia, Latin America, Africa, and parts of the Pacific Islands.

Symptoms of Dengue typically appear 4–10 days after infection and may include:


1.High fever

2.Severe headache

3.Joint and muscle pain (often called "breakbone fever")

4.Skin rash

5.Nausea and vomiting

6.In severe cases, it can lead to Dengue Hemorrhagic Fever or Dengue Shock Syndrome, which can be life-threatening.


Early detection and supportive care are key to effective management and prevention of complications.




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