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The U.S. FDA has granted Siemens an Emergency Use Authorization (EUA) for its real-time PCR Zika Virus assay, the VERSANT Zika RNA 1.0 Assay (kPCR) Kit. With respect to Zika IVD tests, FDA has been authorized to issue EUAs to allow for use of unapproved medical products or unapproved uses of approved medical products when, […]
Aflatoxins are poisonous carcinogens that are produced by certain molds (Aspergillus flavus and Aspergillus parasiticus) which grow in soil, decaying vegetation, hay, and grains. These small molecules are a worldwide health problem considering that as many as 5 billion people may be exposed. Children are particularly affected by aflatoxin exposure, which may lead to stunted […]
The new high-sensitivity troponin I (TNIH) in vitro diagnostics assay is designed to aid in diagnosing acute myocardial infarctions (AMI) through the quantitative measurement of cardiac troponin I in serum or plasma. High-sensitivity troponin plays a critical role in the timely diagnosis of AMI, or heart attacks. The presence of cardiac troponin is specific to […]
Pertussis is a very contagious disease which spreads from person to person usually by coughing or sneezing or when spending a lot of time near one another and sharing breathing space. The most important cause for whooping cough (pertussis) is B. pertussis, followed by B. parapertussis. Bordetella holmesii has been isolated from patients with a […]
The BioPlex 2200 System is the industry’s first fully automated, random access multiplex testing platform. It combines innovative, reliable automation with the diagnostic power of proprietary multiplex chemistry and state-of-the-art eFlex software to bring a new level of flexibility and operational benefits to the laboratory. It improves workflow with random access sampling and priority processing. […]
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 […]
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