On September 7th 2021, the automated CLIA system of Illumaxbio (including lumiflx16, lumiflx16s, lumilite8, lumilite8s) was awarded the Medical Device Registration Certificate (MDRC) by Sichuan Medical Products Administration (SMPA). The Medical Device Registration Certificate refers to an endorsement of the effectiveness and safety of the product and approval of its sale and use in China.
The automated CLIA system delivers lab-quality results at the point of care with the speed needed to enable rapid decision making for better patient care. lumiflx16 and lumiflx16s consist of primary tube module, cleaning-separation-sampling module, reaction module, detection module and software, while lumilite8 and lumilite8s consist of cleaning-separation-sampling module, reaction module, detection module and software. All the core components are self-developed , which greatly reduces the production cost and brings our customers with 5A products. (5A – Anytime . Anyplace . Anyone . Affordable. Accuracy)
The automated CLIA system adopts the chemiluminescence method of alkaline phosphoric acid, and is used in conjunction with an adapter reagent for the qualitative or quantitative detection of analytes in human whole blood, serum and plasma samples, including hormones, tumor-related antigens, proteins and peptides, liver diseases, myocardial diseases, immune functions, infectious diseases, vitamins and blood levels, other enzymes, D-dimer…etc.
The founding team has been working in the IVD industry for around 20 years, which has strong research & development ability and industrialization ability, they are committed to achieving the whole production chain controllable to provide high cost-effective clinical immunoassay and molecular diagnostic systems through the core technology innovation. Illumaxbio currently focuses on three technology platforms, namely, automated CLIA system, automated multiplex immunoassay system and laboratory automation. And it has an industrialization base of nearly 4000 square meters in Chengdu International Medical City. We adhere to openness and cooperation for mutual benefits to provide one-stop service including instrument customization, reagent development and CDMO etc.
We offer OEM & ODM solutions and comprehensive tests such as cardiac, inflammation,fertility,thyroid and tumor marks. We also provide one-stop products and services from instrument customization, reagent matching, CDMO to product registration.
Tel: +86 4006382018
Post time: Sep-07-2021