Roche Receives CE Mark for PCR Test Targeting Bacterial Vaginosis and Candida Vaginitis
The cobas BV/CV assay aims to improve diagnostic accuracy over traditional microscopy and pH testing methods for symptomatic patients.
Tag: CE mark
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Dotz Nano to Showcase Mega-Diagnostic Platform
Dotz Nano will introduce its Mega-Diagnostic Platform for en masse, rapid diagnosis of COVID-19 at the point of care.
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Roche to Launch SARS-CoV-2 Rapid Antigen Test Nasal
The SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose instead of the nasopharynx, and can be self-collected.
PerkinElmer Covid-19 RT-PCR Assay Gets CE Mark for Saliva, Sample Pooling
The assay received CE-IVD marking for the use of saliva as specimen type and the option to pool up to five specimens collected from individuals suspected of covid-19 or asymptomatic individuals.
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Ortho Optix Reader Now Available in CE Mark Countries
The Ortho Optix Reader’s high-resolution camera captures color, grayscale, front and back images of each test without operator intervention.
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Siemens Healthineers Quantitative Covid-19 Test Measures Neutralizing Antibodies
The SARS-CoV-2 IgG Antibody Test (sCOVG) is an enhanced version of the assay which became available globally this summer.
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PerkinElmer Receives CE Mark for Multianalyte Respiratory Panel Including Covid-19
The PKamp Respiratory SARS-CoV-2 RT-PCR Panel enables differential diagnosis between covid-19, flu, and RSV infections.
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FDA Accepts Ortho’s Emergency Use Notification for Vitros Covid-19 Antigen Test
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.
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Admetsys PrecisionOne Automated Glycemic Control System Gets CE Mark
The PrecisionOne system functions as a metabolic autopilot, providing automated glucose regulation and real-time analysis of blood chemistry values for critical care patients.
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Biocartis Releases SeptiCyte Rapid Test on Idylla
SeptiCyte Rapid distinguishes sepsis from non-infectious systemic inflammation in patients suspected of sepsis and provides actionable results in about 1 hour.
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BD Rapid POC Covid-19 Antigen Test Gets CE Mark
The new BD covid-19 antigen test delivers results in 15 minutes on the portable BD Veritor Plus System.
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Roche to Launch Covid-19 Rapid Antigen Test in Europe
Roche will launch a covid-19 Rapid Antigen Test in late September for markets accepting the CE Mark.
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Zymo Research Granted CE IVD Mark for Quick SARS-CoV-2 rRT-PCR Kit
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.
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Natera’s Signatera ctDNA Assay Test Receives CE Mark
The Signatera test is a personalized, tumor-informed ctDNA assay optimized for molecular residual disease assessment and treatment monitoring.
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Assay Detects and Differentiates Trichomonas vaginalis and Mycoplasma genitalium in Urine
The NeuMoDx TV/MG assay implemented on the NeuMoDx Molecular system allows for automated detection of T. vaginalis and M. genitalium simultaneously.
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Roche Receives CE Mark for Accu-Chek SugarView Smartphone App
The app will enable broader access to therapy-relevant information for non-insulin-dependent people with type 2 diabetes or prediabetes.
Read MoreNGS Diagnostic Platform Granted CE Certification
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.
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GenePOC Carba Test Receives CE Mark
The assay is intended to help stop the spread and transmission of carbapenem-producing organisms.
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