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 […]
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, […]
The Yumizen H500 CT ‘Closed Tube’ provides enclosed, cap-piercing sample handling to meet the health and safety demands of the laboratory environment. The Yumizen H500 family provides a cost-effective hematology profile for small to mid-size laboratories and clinics. The Yumizen H500 will produce a raPid and comprehensive hematology diagnosis. It is a compact and robust […]
The Arcis DNA Blood Kit (IVD) is now available for preparation of DNA from blood using a novel three minute two step system, designed for in vitro diagnostic use. The new kit is sold in a ready-to-use format, and enables users to stabilize and extract nucleic acid from fresh or frozen whole blood samples in […]
Siemens Healthineers has recently launched the CE-marked Atellica COAG 360 System, a fully automated high-volume coagulation analyser designed to streamline and unify hemostasis testing. The Atellica COAG 360 System is the first analyser to unify five methodologies on one testing platform – clotting (optical and optomechanical), chromogenic, immunologic, high-sensitivity luminescence based immunoassay (LOCI) technology, and […]
Unlike traditional pipettes which utilize a single rotating plunger to set volumes, the new EVOLVE manual pipette range from INTEGRA features an innovative approach that allows users to set volumes more than ten times faster. Available in single, eight and twelve channel formats, covering a volume range of 0.2 – 5,000 ?l, the ultralightweight, well […]
Different from the previous test versions, the new GastroPanel Quick test is designed for the point-of-care (POC) measurement of four stomach- specific biomarkers in the blood: pepsinogen I (PGI), pepsinogen II (PGII), gastrin-17 (G-17) and Helicobacter pylori IgG antibodies. In the new test version, sample processing is based on a lateral flow (LF) principle, with […]
A new connectivity package for EKF’s Quo-Test and Quo-Lab HbA1c analysers enables secure bidirectional communication between these POC analysers and a multitude of central data management systems. Using the industry recognized POCT1-A2 communication protocol, EKF’s connectivity solution unlocks a host of new features aimed at improving security and quality control (QC) for diabetic HbA1c testing. […]
The multiparameter component-based test EUROLINE DPADx Peanut allows differentiation of primary peanut allergy from pollen-associated cross reactions, enabling assessment of the patient’s risk for severe reactions. In the test, specific IgE antibodies against seven defined components from peanut and the major birch pollen allergen Bet v 1 are analysed in parallel using immunoblot technology. Patients […]
Launched in Europe, the CE-IVD marked calreticulin (CALR) mutation assay aids in establishing the diagnosis of myeloproliferative neoplasms (MPN). The new ipsogen CALR RGQ PCR Kit (ipsogen CALR assay) is intended for the detection of CALR mutations in genomic DNA from subjects suspected of MPN. It enables identification of the two majors CALR mutations, Type […]
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