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In Vitro Diagnostic Ivd Articles & Analysis

10 news found

Diving Deeper in Rare Disease Research: Protheragen Unveils Diagnostic Development Services

Diving Deeper in Rare Disease Research: Protheragen Unveils Diagnostic Development Services

By providing innovative diagnostic tools and support, we empower researchers to take significant steps toward effective treatments.” Protheragen’s rare disease diagnostic development services cover in vitro diagnostic (IVD) product development, point-of-care test (POCT) development, laboratory ...

ByProtheragen


Alfa Chemistry Announces the Launch of Innovative IVD Products for Laboratory Use

Alfa Chemistry Announces the Launch of Innovative IVD Products for Laboratory Use

In vitro diagnostics (IVD) are tests done on samples such as blood or tissue for the purpose of detecting diseases or other conditions. ...

ByAlfa Chemistry


New IVD System Enables Assay Developers and Clinical Laboratories to Accelerate Molecular Diagnostics Growth

New IVD System Enables Assay Developers and Clinical Laboratories to Accelerate Molecular Diagnostics Growth

As assay developers and clinical testing laboratories consider next steps for molecular diagnostics post-pandemic, a new in vitro diagnostic (IVD) system from Thermo Fisher Scientific will enable them to expand their assay menus and IVD testing capabilities moving forward. ...

ByThermo Fisher Scientific


Sebia and METAFORA biosystems form strategic partnership to develop advanced in vitro diagnostics

Sebia and METAFORA biosystems form strategic partnership to develop advanced in vitro diagnostics

Sebia, a world leader in diagnostics in the fields of multiple myeloma and chronic diseases, and Metafora biosystems ("Metafora") today announced a strategic partnership to develop a portfolio of in-vitro diagnostics (IVD) solutions based on Metafora's technology platform. Metafora leverages a single-cell Al-powered ...

ByMetafora Biosystems


Bio-Techne`s Exosome Diagnostics Laboratory Announces CE-IVD Certification for Exodx Prostate Test

Bio-Techne`s Exosome Diagnostics Laboratory Announces CE-IVD Certification for Exodx Prostate Test

Bio-Techne Corporation (NASDAQ:TECH) today announced that Exosome Diagnostics, a Bio-Techne brand, has completed its clinical validation of an in vitro diagnostic (IVD) version of the ExoDx™ Prostate test (EPI) kit enabling self-certification as CE-IVD as of March 22, 2021. Bio-Techne Corporation ...

ByExosome Diagnostics, Inc.


Abionic Signs Agreement to Optimize Asthma Management in the U.S. through Innovative Rapid Point-of-Care Tests

Abionic Signs Agreement to Optimize Asthma Management in the U.S. through Innovative Rapid Point-of-Care Tests

Abionic SA, the developer of proprietary disruptive nanotechnology based rapid diagnostic solutions, and Genentech, a member of the Roche Group, announced today a strategic agreement to develop and provide an In Vitro Diagnostic (IVD) Asthma Test Panel using Abionic’s POC abioSCOPE® platform in the United States. ...

ByAbionic SA


New Expanded Analytical Instrument Portfolio of U.S. FDA Class I Medical Devices for Clinical Diagnostic Laboratories

New Expanded Analytical Instrument Portfolio of U.S. FDA Class I Medical Devices for Clinical Diagnostic Laboratories

The portfolio enables clinical diagnostic laboratories to leverage a comprehensive platform for developing sensitive and reliable laboratory developed tests (LDTs). ...

ByThermo Fisher Scientific, LIMS & Laboratory Software


Metaglut1, A New Diagnostic Test for the Glut1 Deficiency Syndrome

Metaglut1, A New Diagnostic Test for the Glut1 Deficiency Syndrome

The METAglut1 test is a true medical innovation, the first ever diagnostics test to illustrate a dysfunction in cells’ nutrition and was just CE marked at the end of January. ...

ByMetafora Biosystems


ELITechGroup Molecular Diagnostics announce the CE-IVD marking of the CRE ELITe MGB Kit, for the detection of the Carbapenem Resistance genes of Enterobacteriaceae

ELITechGroup Molecular Diagnostics announce the CE-IVD marking of the CRE ELITe MGB Kit, for the detection of the Carbapenem Resistance genes of Enterobacteriaceae

ELITechGroup Molecular Diagnostics announce today the CE-IVD marking of the CRE ELITe MGB kit, a high-performance, qualitative, multiplex assay for the rapid detection of the Carbapenem Resistance genes of Enterobacteriaceae. ...

ByELITechGroup


BSI expediting expansion of in vitro diagnostic scope for medical devices

BSI expediting expansion of in vitro diagnostic scope for medical devices

BSI, a world-class Notified Body providing regulatory and quality management reviews and product certification for medical devices, is rapidly implementing plans to expand its medical device Notified Body scope to include in vitro diagnostic (IVD) devices. BSI has appointed Sue Spencer, an IVD industry veteran, to lead what looks ...

ByBSI Consulting

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