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Bio-Rad 40 Exact Diagnostics-Branded Infectious Disease Molecular QC Products Receive IVDR Quality Certificate

Bio-Rad has achieved the IVDR certification of 40 Exact Diagnostics-branded infectious disease molecular quality controls.

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EuroImmun Launches SARS-CoV-2 NeutraLISA Assay

The EuroImmun SARS-CoV-2 NeutraLISA assay is a surrogate neutralization test intended for the detection of neutralizing antibodies against SARS-CoV-2, the pathogen causing covid-19.

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Maverick Portable qPCR Gets CE-IVD for Nucleic Acid Test

Maverick's CMOS 4-channel fluorescence optics system allows fast and highly multiplexed DNA detection without the need for field calibration.

Siemens Healthineers Quantitative Covid-19 Test Measures Neutralizing Antibodies

Nov 19, 2020 | Covid 19, Diagnostic Technologies

The SARS-CoV-2 IgG Antibody Test (sCOVG) is an enhanced version of the assay which became available globally this summer.

PerkinElmer Receives CE Mark for Multianalyte Respiratory Panel Including Covid-19

Nov 18, 2020 | Covid 19, Flu & Respiratory Infections, Immunoassay Reagents & test Kits

The PKamp Respiratory SARS-CoV-2 RT-PCR Panel enables differential diagnosis between covid-19, flu, and RSV infections.

FDA Accepts Ortho’s Emergency Use Notification for Vitros Covid-19 Antigen Test

Nov 10, 2020 | Covid 19

Compared to PCR, Ortho’s test may be better able to identify individuals with covid-19 who are infectious because the test is offered with 100% sensitivity.

Admetsys PrecisionOne Automated Glycemic Control System Gets CE Mark

Oct 26, 2020 | Clinical Chemistry, Diabetes & Metabolic Diseases

The PrecisionOne system functions as a metabolic autopilot, providing automated glucose regulation and real-time analysis of blood chemistry values for critical care patients.

Biocartis Releases SeptiCyte Rapid Test on Idylla

Oct 9, 2020 | Rapid Assays

SeptiCyte Rapid distinguishes sepsis from non-infectious systemic inflammation in patients suspected of sepsis and provides actionable results in about 1 hour.

BD Rapid POC Covid-19 Antigen Test Gets CE Mark

Sep 30, 2020 | Covid 19, POC Rapid Assays, Rapid Assays

The new BD covid-19 antigen test delivers results in 15 minutes on the portable BD Veritor Plus System.

Roche to Launch Covid-19 Rapid Antigen Test in Europe

Sep 2, 2020 | Covid 19, Rapid Assays

Roche will launch a covid-19 Rapid Antigen Test in late September for markets accepting the CE Mark.

Zymo Research Granted CE IVD Mark for Quick SARS-CoV-2 rRT-PCR Kit

Sep 1, 2020 | Covid 19, Molecular Diagnostics

This kit features a limit of detection as low as 15 GEC per reaction and includes ready-to-use reaction mixtures to reduce hands-on time.

Natera’s Signatera ctDNA Assay Test Receives CE Mark

Aug 28, 2020 | Cancer, Molecular Diagnostics

The Signatera test is a personalized, tumor-informed ctDNA assay optimized for molecular residual disease assessment and treatment monitoring.

Assay Detects and Differentiates Trichomonas vaginalis and Mycoplasma genitalium in Urine

Apr 6, 2020 | Infectious Diseases, Molecular Diagnostics, Sexually Transmitted Diseases

The NeuMoDx TV/MG assay implemented on the NeuMoDx Molecular system allows for automated detection of T. vaginalis and M. genitalium simultaneously.

Roche Receives CE Mark for Accu-Chek SugarView Smartphone App

Feb 7, 2020 | POC Instruments, Point-of-Care

The app will enable broader access to therapy-relevant information for non-insulin-dependent people with type 2 diabetes or prediabetes.

NGS Diagnostic Platform Granted CE Certification

Oct 15, 2019 | Sepsis, Transfusion & Transplantation Tests

Disqver uses next-generation sequencing of cell-free DNA to detect more than 1,500 bacteria, DNA viruses, fungi, and parasites in a patient’s bloodstream.