Product News

With the continuous progress of science and technology and the continuous development of medical technology, Point-of-Care Testing (POCT) has become one of the important tools in the modern medical field.

Congratulations, Wizbiotech's one product has received MDA approval from the Malaysian Medical Device Regulator : Enterovirus 71 IgM Antibody Test Kit (Colloidal gold method)!

A-group Rotavirus is the most common pathogen causing diarrhea in infants aged 6 to 24 months, and is also one of the leading causes of infant mortality. In the early stages of A-group Rotavirus infection, some children may experience frequent vomiting followed by diarrhea.

Mycoplasma pneumoniae (MP) is a microorganism that falls between a virus and a typical bacterium, belonging to the genus Mycoplasma. It can attach to the surface of the respiratory mucosa, causing lung infections. Due to the lack of cell wall structure found in bacteria, Mycoplasma pneumoniae is resistant to antibiotics that target bacterial cell walls, such as penicillin and cephalosporin.

We are delighted to announce that another one of our product, the Diagnostic Kit of Cardiac Troponin I (Fluorescence Immunochromatographic Assay), has been approved by the Malaysian Medical Device Authority (MDA).

Warm congratulations, a product of Wizbiotech has been approved by MDA, the Malaysian medical device regulatory agency.

Warm congratulations, Wizbiotech's three products have been approved by the Malaysian medical device regulatory agency MDA

WIZ's two reagents, HBA1C assay kits (fluorescent immunochromatography) and the SARS-CoV-2 Antigen Rapid Test (Colloidal gold) (Anterior nasal) have been approved by the Medical Device Authority (MDA) of Malaysia and began market access.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has announced that 66 WIZ products have received UKCA certification. It means that WIZ products are officially certified for quality and safety, and can be legally sold and used in the UK and other countries and territories that recognize the UK UKCA registration.

December 20th, 2022, Wizbiotech Glycosylated Hemoglobin A1c and 25-hydroxy Vitamin D test kit obtain UKCA registration, which marks the possiblity to enpower British health management.