BioArtron continuously monitor the environment and actively engaged in making improvements to offer best experience to our customers.
BIOARTRON DIAGNOSTICS INC. is pleased to announce its completion of the registration of a total of 32 In Vitro Diagnostic (IVD) detection products with CIBG Ministerie van Volksgezondheid, Welzijn en Sport of the Netherlands under the EU In Vitro Diagnostics Directive (IVDD) 98/79/EC.
These 32 different types of IVD detection products adopt the latest Magnetic-particle Chemiluminescence Immunoassay (MCLIA) technologies and are compatible to BIOARTRON’s Lumilizer iA2000 analyzer. The registered IVD detection products cover 6 major test panels such as Thyroid Function, Cardiac Markers, Gonadal Hormones, Tumor Markers, Diabetes and COVID-19.
BIOARTRON is currently marketing globally the MCLIA diagnostic systems including Lumilizer iA2000 and the compatible detection kits to help build a better world.
BIOARTRON DIAGNOSTICS INC. is pleased to announce that a Medical Device Licence (Licence No. 107200) is issued to BIOARTRON for its Lumilizer iA2000 chemiluminescence immunoassay analyzer by Health Canada under the Device Class 2 in accordance with the Medical Devices Regulations, Section 36 of Canada.
The Lumilizer iA2000 now is a fully automated magnetic-particles chemiluminescence immunoassay analyzer both CE-registered and Health Canada-licenced. This instrument completed its CE IVDR registration earlier in October 2021.
BIOARTRON DIAGNOSTICS INC. today announced the registration of Lumilizer iA2000 chemiluminescent immunoassay analyzer with CIBG Ministerie van Volksgezondheid, Welzijn en Sport of the Netherlands under the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746.
Lumilizer iA2000 is a fully-automated chemiluminescence immunoassay analyzer launched by BIOARTRON in 2021 which adopted the new generation technologies of Magnetic particle-based Chemiluminescence Immunoassay (MCLIA) to offer high detection sensitivity and specificity and quick result outputs for the assistance of clinical diagnosis as well as other health-related applications.
MCLIA has received much attention in not only clinical testing and diagnosis for diseases and health conditions, such as tumors screening, cardiac conditions, hepatitis, diabetes, infectious diseases, allergens, anemia, etc., but also applied to non-clinical fields such as food safety test, veterinary drugs, pesticide residues, stimulant detection, and environmental analysis.
BIOARTRON is dedicated to offering the most valuable diagnostic and test solutions to every invaluable customer and family in Canada and around the globe.