Recently, the TSure Nucleic Acid Analysis Device independently developed by Sansure obtained CE mark, which will further meet and expand the global testing market demands at all levels, and serve the construction of public health prevention and control system in every country better.s
Roche announced on Tuesday that it is launching three new tests on its molecular Cobas 5800 instrument in countries accepting the CE mark.
Belgian molecular laboratory software vendor UgenTec said Thursday that it has entered into a deal with Thermo Fisher Scientific to jointly commercialize several new CE-marked respiratory assay plug-ins for its FastFinder analysis software.
MagBio Genomics said on Monday that it has received US Food and Drug Administration 510(k) clearance, as well as CE marking, for its MagXtract Collection Tube for viral sample collection.
BGI Genomics said on Thursday that it has received CE-IVD marking for its next-generation sequencing-based test for thalassemia mutation detection.
SkylineDx said on Thursday that it has obtained CE-IVD marking for its Merlin Assay to predict which melanoma patients are at low risk of nodal metastasis.
Thermo Fisher Scientific said on Tuesday that it has received CE-IVD marking for its Oncomine Dx Express Test, a next-generation sequencing tumor mutation profiling test, and the companion Oncomine Reporter Dx analysis software and has launched them.
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. obtained the CE extension certificate issued by TüV SüD, a famous EU notified body under the IVDR regulations.
Roche said on Wednesday that its Ventana PD-L1 test has received a CE label expansion for its Ventana PD-L1 SP263 test to determine non-small cell lung cancer patients' eligibility for Roche's immune checkpoint inhibitor Tecentriq (atezolizumab).
CorDx said on Wednesday that it has received CE marking for a monkeypox virus antigen test.
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