Snibe
received the CE certificate (List A) for MAGLUMI® HBsAg (CLIA) assay On March 11,
2022. It further proves the high reliability of the quality and performance of
Snibe products, as well as a verification of Snibe’s leading position in the
field of chemiluminescence.
Based on assessment of
sequences and bioinformatics analysis, we confirm that Snibe’s assays for
detection of the SARS-CoV-2 virus in the table below are effective in detecting
SARS-CoV-2 variants reported by WHO including B.1.1.529 (Omicron), B.1.1.7 (Alpha),
B.1.351 (Beta), P.1 (Gamma), B.1.617.2 (Delta),C.37
(Lambda), B.1.617.1 (Kappa), etc.
From August 29th to 31st, 2019, the 15th National Congress of Laboratory Medicine (NCLM 2019), hosted by Chinese Medical Association and Chinese Society of Laboratory Medicine, was held at Suzhou International Expo Centre.
On December 15, 2020, Snibe's MAGLUMI® TSH assay and MAGLUMI® CA 19-9 assay were certified the IVDR CE Certification by TÜV SÜD Product Service GmbH an EU Notified Body, making Snibe one of the first IVDR CE-certified manufacturers for CLIA products in Asia.
Shenzhen, China, 14 April 2021 - Snibe received the approval of the CE certificate (List A) for the HIV Ab/Ag Chemiluminescence Immunoassay (CLIA) assay.
Shenzhen, China, 22nd February, 2021-Snibe launches MAGLUMI® SARS-CoV-2 Ag with CE mark, which is a reliable chemiluminescence immunoassay solution for the quantitative detection of nucleocapsid antigens of SARS-CoV-2 from suspected COVID-19 patients. Besides, the SARS-CoV-2 Antigen Test aids to the early detection of SARS-CoV-2 virus from acute COVID-19 infection.