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Tag: companion diagnostic

CHMP Q&A Document on Development and Assessment for Companion Diagnostic Products | CHMP

Medical Devices
The article highlights the key points associated with the regulatory framework for specific categories of medicinal products. Table of content ...

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Qiagen unveils IVD platform for automated sampling in laboratories

Medical Devices
<!----> Qiagen has launched the EZ2 Connect MDx IVD platform for automated sampling in diagnostic laboratories. The company...

Full List of 181 Guidelines Issued by NMPA in 2022

Medical Devices
titlestatusdateGuideline on Metal Plate Internal Fixation SystemFinal17-JanGuideline on Disposable High Pressure Contrast Syringe and AccessoriesFinal17-JanBiosafety Cabinet Registration and Review GuidelineFinal19-JanGuideline on Medical Device Product...

Malaysian Genomics Explores R&D Collaboration with SIRIM

Blockchain
PETALING JAYA, Malaysia, Jan 9, 2023 - (ACN Newswire) - Malaysian Genomics Resource Centre Berhad (Bursa: MGRC, 0155), a leading genomics and biopharmaceutical specialist, is pleased to announce...

Agilent and Akoya partner to develop multiplex assays for tissue analysis

Medical Devices
<!----> Agilent Technologies and Akoya Biosciences have collaborated to develop multiplex-immunohistochemistry diagnostic products for tissue analysis. The companies...

Companion Diagnostic: Overview of the Regulation

Medical Devices
According to the definition provided by European Medicine Agency (EMA), a companion diagnostic is an in-vitro diagnostic test that supports the safe and effective use of a specific medicinal...

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