7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Denmark
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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
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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
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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