10 results
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23ms
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Sources: EU EUDAMED, US FDA
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Country: Denmark
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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
BrainCapture ApS
Manufacturer
🇩🇰 Denmark·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Fecal Occult Blood (FOB) Test (Colloidal Gold)
Basic UDI-DI
EU IVDD
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Eu Ivd General
·BGI EUROPE A/S·1 device
Fecal Occult Blood (FOB) Test (Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·BGI EUROPE A/S·1 device
Fecal Occult Blood (FOB) Test (Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·BGI EUROPE A/S·1 device
Fecal Occult Blood (FOB) Test (Colloidal Gold)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·BGI EUROPE A/S·1 device
MDR-007
Certificate
MDR QMS·BrainCapture ApS·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Abena A/S
Importer
🇩🇰 Denmark·20 Manufacturers