Product News

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.

Recently, the new coronavirus (2019-nCoV) antigen detection kit (Colloidal gold method) developed by Xiamen Wiz Biotech Co., Ltd. has been approved by the National Medical Products Administration.

Recently, the portable immune analyzer WIZ-A101 from Wizbiotech has obtained the IVDR CE certification.

According to the latest HSC Common List published on October 17, 2022, the SARS-CoV-2 Antigen Rapid Test produced by Wizbiotech has been listed in HSC Common List Class A.

"Continuous Immune Analyzer WIZ-A202" independently developed by Xiamen Wiz Biotech Co., LTD obtained Fujian Medical Device Registration Certificate on March 31, 2017 [Min Instrument Registration: 20172400081].

The product diagnostic Kit for IgM Antibody to C. pneumoniae(Colloidal Gold) was approved by CFDA! Up to now, Wiz has 15 product certificates in China!