Promise proteomics

mAbXmise monoclonal antibodies quantification kits are In Vitro Diagnostic Medical Devices for laboratory professional use and CE-IVD labeled for Europe by BSI. Assay results are intended to be used by healthcare professionals. The kits are designed to perform absolute quantification by LC-MS (Liquid Chromatography – Mass spectrometry) of specific therapeutic monoclonal antibodies (mAbs) in a patient sample. Assay results are intended to be used by healthcare professionals. Before use, it is important to carefully read the instructions provided with the product. The products are non-refundable. The mAbXmise Kit described has not been cleared by any regulatory entity for diagnostic purposes outside of Europe. Proteomics mAbXmise Kits are not available for sale in all countries.

From the manufacturer's own website. Source

Promise proteomics manufactures mAbXmise, a series of in vitro diagnostic medical devices designed for laboratory professionals. These kits quantify specific therapeutic monoclonal antibodies (mAbs) in patient samples using liquid chromatography–mass spectrometry (LC-MS) for absolute measurement.

The mAbXmise kits are classified as Class B in vitro diagnostic devices and are listed in the EU’s eudamed registry. They are CE-IVD marked for use within the European Union, adhering to applicable regulatory standards for diagnostic medical devices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.