7 results · 26ms · Sources: EU EUDAMED, US FDA

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Reapplix A/S

Manufacturer
🇩🇰 Denmark·1 Basic UDI-DI·1 Device·Eurofins Electric & Electronics Finland Oy

3C Patch Device

Device
EU MDD · Eu Md Class 2a ·Reapplix A/S·On the market·5 countries

Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2 Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable

FDA Enforcement
Class II ·Ongoing·Agilent Technologies Denmark ApS·September 24, 2025

Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2J Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable

FDA Enforcement
Class II ·Ongoing·Agilent Technologies Denmark ApS·September 24, 2025

Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2CN Software Version: Not applicable Product Description: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) is intended for use in immunohistochemistry together with the Dako Omnis instrument. This antibody labels cells of the B-cell lineage and is a useful aid for the classification of neoplasms of B-cell derivation. Component: Not applicable

FDA Enforcement
Class II ·Ongoing·Agilent Technologies Denmark ApS·September 24, 2025

3C Patch Device

Basic UDI-DI
EU MDD · Eu Md Class 2a ·Reapplix A/S·1 device

C-01-1210-718-19

Certificate
MDD Annex II (excluding section 4)·Reapplix A/S·Eurofins Electric & Electronics Finland Oy·1 Basic UDI-DI