BEUDAMED
    10 results · 18ms · Sources: EU EUDAMED, US FDA

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    DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440

    FDA 510(k)
    FDA Class 1 ·Microbiology

    FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)

    FDA 510(k)
    FDA Class 2 ·Hematology

    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

    FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)

    FDA 510(k)
    FDA Class 2 ·Hematology

    Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.

    FDA Enforcement
    Class II ·Terminated·Dako Denmark A/S·May 27, 2020

    CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to hold microscopic slides, during transfer through the staining process. The rack can hold up to 10 slides at a time, and is necessary for optimal CoverStainer instrument performance.

    FDA Enforcement
    Class II ·Terminated·Dako Denmark A/S·December 26, 2012

    EnVision FLEX+, Mouse, High pH (Link), Product No. K8002, K8004. Intended for use in immunohistochemistry together with Autostainer Link Instruments.

    FDA Enforcement
    Class II ·Terminated·Dako Denmark A/S·August 10, 2016

    Bureau Medica Intercert DK

    Authorized representative
    🇩🇰 Denmark·2 Manufacturers