Os 2 produtos da WIZ são registrados e aprovados na Malásia
Two of WIZ's products have recently been approved by Malaysia's medical device regulator MDA: Diagnostic Kit for D-Dimer (fluorescence immunochromatographic assay), Diagnostic Kit for Dengue NS1 Antigen (Colloidal Gold), this achievement marks a further increase in WIZ's recognition in the international market.
The D-dimer Assay kit is a product for the quantitative determination of D-dimer (D-D) present in human plasma/whole blood samples in vitro to assist in the diagnosis of venous thrombosis, disseminated intravascular coagulation and monitoring of thrombolytic therapy. D-dimer is a fibrin degradation product formed during coagulation, and its content is closely related to many diseases, especially cardiovascular diseases and thrombotic diseases. Therefore, the accurate determination of D-dimer is of great significance for the early diagnosis and treatment of diseases.
To meet the needs of rapid clinical testing, the D-dimer assay kit can be combined with WIZ's convenient immunoassay instrument, the WIZ-A101. The WIZ-A101 is a compact, easy-to-use immunoassay instrument that delivers rapid quantitative results and is ideal for clinical Settings that require rapid decision making, such as the emergency room. By using this instrument, doctors can quickly obtain accurate data on D-dimer content, providing timely support for diagnosis and treatment.
Dengue fever is a mosquito-borne viral disease, which seriously threatens the life and health of people in tropical and subtropical areas. NS1 antigen is an important marker of dengue virus, and its detection plays a key role in the early diagnosis and control of dengue. WIZ's dengue NS1 antigen test kit uses colloidal gold, a fast and easy test that provides accurate test results in a short period of time, which is of great value for timely detection and control of dengue outbreaks.
The approval of these two products not only demonstrates WIZ's strength in the development and production of high-quality medical devices, but also demonstrates MDA Malaysia's rigorous standards in ensuring the safety and effectiveness of medical devices. As a multicultural country, Malaysia's medical device market has great potential and room for development. The entry of WIZ products will provide more choices for medical institutions in Malaysia, and will also promote the improvement of local medical and health standards.
