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The SCIEX Topaz System is designed specifically to meet the unique needs of the clinical diagnostic lab, lowering the barriers to adoption of LC-MS and making it accessible to the entire clinical lab staff. The heart of the system lies within the innovative ClearCore MD software, a platform which simplifies and streamlines workflows and method […]
An LC-MS/MS-based clinical diagnostic solution that is CE marked to the IVDD 98/79/EC for quantitative assessment of vitamin D status in human plasma and serum.The MassTrak Vitamin D Solution includes: instrumentation with the ACQUITY UPLC I-Class/Xevo TQD IVD System, reagents and consumables, services, and informatics. Obtain accurate, precise, linear, and sensitive results with the Waters MassTrak […]
The ScanStation is a real-time incubator and colony counting station designed for the pharmaceutical, agro-food and cosmetic industries as well as research. It provides centralized incubation, detection and colony counting of 100 Petri dishes simultaneously. In classical Pasteurian microbiology, the Petri dish must be placed in an incubator for 24h and up to 5 days. […]
Edan is expanding its product line into the In-vitro diagnostics area by cooperating with BIT-Messer, Germany, who has accumulated experience in the IVD field for decades. The new line, consisting of a 3-part hematology analyser, is the culmination of that effort. Compact yet powerful, full featured yet affordable, simple yet reliable, the H30 provides 20 […]
Bio-Rad Laboratories has made its entry into the rapidly growing molecular diagnostics testing market with the launch of Amplichek II quality control, which was recently issued a de novo clearance from the U.S. Food and Drug Administration (FDA). The FDA’s de novo clearance is a classification given to devices that are considered novel, with no […]
Carnitine/acylcarnitines screening is the most important part of the clinical laboratory diagnosis of amino acid, fatty acid or organic acid metabolism disorders. Carnitine / acylcarnitines screening allows the diagnosis of over 30 metabolic diseases from a drop of blood sample taken with a screening card. This screening test is performed by measurement of carnitine / […]
The newly CE marked FilmArray Respiratory Panel 2 plus (RP2plus) tests for 22 pathogens (18 viruses and 4 bacteria) responsible for respiratory tract infections. It advances the existing FilmArray Respiratory Panel (RP) by reducing the assay time from about an hour to less than 45 minutes, improving overall sensitivity, and updating several assays. FilmArray RP2plus […]
Ortho Clinical Diagnostics received CE Mark approval for its VITROS HIV Combo test. An important addition to the company’s infectious disease portfolio, the new test is available for purchase in Europe and other countries that accept CE Mark since June 2016. The VITROS HIV Combo, a fourth-generation assay, detects both HIV-1 and HIV-2 antibodies and […]
Beckman Coulter Diagnostics announced recently that it has received CE-Mark clearance for a new high-sensitivity troponin (hsTnI) assay that aids in diagnosing myocardial infarction for patients presenting with chest pain or other ischemic symptoms. The high-sensitivity assay provides much greater precision at very low levels of troponin. This gives clinicians greater confidence in interpreting test […]
ELITechGroup Molecular Diagnostics announces the CE-IVD marking of the STI ELITe MGB Panel: a multiplex assay for the detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Mycoplasma genitalium (MG), three major bacteria involved in sexually transmitted infections. STIs are a global burden with more than 1 million infections acquired every day worldwide. Accurate and […]
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