CE mark

NanoSpot.ai launches AI-based SARS-CoV-2 antibody test
The test uses an agglutination-based method combined with an artificial intelligence (AI)-enabled mobile application to deliver semi-quantitative antibody test results at the point of care.
February 28, 2023
Covid 19 Antibody Social
Tasso nabs CE Mark for high-volume liquid blood collection device
Users collect blood through a virtually painless process that can be completed at home, the firm said.
February 14, 2023
Lab Blood Woman2 Social
Roche launches next-gen COVID-19 rapid tests for professional use and self-testing
Roche is building on a broad portfolio of COVID-19 rapid tests with three new test configurations that feature an improved capture antibody and the addition of new digital data sharing capabilities.
October 12, 2022
Covid Diagnostic Test Kit Social
Virax Biolabs nabs CE Mark for monkeypox rapid antigen test
The test kits are used in point-of-care settings, providing results in 15 minutes to help healthcare professionals identify a monkeypox infection in people suspected of carrying the virus, Virax Biolabs said.
September 19, 2022
2022 05 26 14 35 1895 Monkeypox Virus 400
Qiagen developing, releasing assays for NeuMoDx system
The assays, which permit the identification and quantification of the Epstein-Barr virus (EBV) and human herpesvirus 6 (HHV-6), have received CE-IVD certification for use in countries in the European Union and other countries that accept the CE Mark, Qiagen said.
September 15, 2022
2019 05 15 20 52 2340 Lab Pcr Tubes Dna 400
MagBio Genomics secures 510(k), CE Mark approval
A guanidine-free molecular transport medium, the MagXtract Collection Tube eliminates the risk of accidentally creating cyanide gas during cleaning, directly lyses cells during transport, inactivates pathogens, and maintains ambient temperature stability of RNA samples for up to eight days, thus eliminating the need for cold storage and shipping, the firm said.
September 11, 2022
2019 02 13 19 24 5396 Fda Logo V2 400
CorDx obtains CE Mark for monkeypox tests
The three tests are the following:
August 24, 2022
2022 05 26 14 35 1895 Monkeypox Virus 400
Nanostics secures CE Mark for ClarityDx Prostate
ClarityDx Prostate, which detects and measures extracellular vesicles, is based on a machine-learning algorithm that combines data from biological and clinical biomarkers to generate a risk score for prostate cancer that has a Gleason grade group 2 or higher on prostate biopsy.
August 22, 2022
2021 02 13 00 35 3916 Prostate Cancer 400
GenScript launches monkeypox PCR test
The kit, which was developed in partnership with Anbio Biotechnology, can be ordered now by diagnostic labs and medical device distributors to be used in research to detect the monkeypox virus.
August 17, 2022
2022 07 13 19 56 4243 3 D Monkeypox Infecting Cell 400
Predicine brings cell-free DNA assay to Europe
The targeted next-generation sequencing assay, which has received the CE Mark, is designed to detect single nucleotide variants (SNVs), insertions and deletions (indels), DNA rearrangements (fusions), and copy number variations (CNVs) in patients diagnosed with cancer, according to the vendor.
August 9, 2022
2020 08 19 15 41 6302 Dna Pcr Ngs 400
Imspex lands CE Mark for COVID-19 breath test
A breath analyzer based on a combination of gas chromatography and ion mobility spectrometry technologies, BreathSpec is designed for use in a point-of-care setting by clinicians and nontechnical users in diagnosing respiratory tract infections, with specific utility for COVID-19, according to the Wales-based vendor.
August 8, 2022
2021 11 12 17 39 5991 Coronavirus Covid Blue 400
Seegene outlines expansion strategies at AACC 2022
At AACC, the company displayed its fully automated Starlet-Aios (all-in-one system) for which it has obtained the CE-IVDR Mark.
July 28, 2022
2022 05 27 20 42 7840 Doctor Lab Test Bipoc 400
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