BEUDAMED
    10,000 results · 49ms · Sources: EU EUDAMED, US FDA

    Aptima Combo 2®

    FDA UDI
    Hologic, Inc.·15420045505735·Aptima Combo 2® Assay, 100 test, box 1 of 2 (2°...

    Aptima®

    FDA UDI
    Hologic, Inc.·15420045506237·The Aptima® Controls Kit is for use with the Ap...

    QUANTA Flash dsDNA

    FDA registration
    INOVA DIAGNOSTICS, INC.·3 products·🇺🇸 United States

    Vysis CEP X Spectrum Orange/CEP Y Spectrum Green (07J20-050, 07J22-050)

    FDA registration
    ABBOTT MOLECULAR, INC.·2 products·🇺🇸 United States

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    FDA Pre-Market Approval
    FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx (F1CDx)

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND HYBRID CAPTURE HPV DNA TEST

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC 3F AORTIC BIOPROSTHESIS MODEL 1000

    Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

    FDA Pre-Market Approval
    FDA Class 3 ·UROVYSION BLADDER CANCER KIT

    Genomic column DNA Express

    Device
    EU IVDR · Eu Ivd Class A ·Sacace Biotechnologies S.r.l·On the market·32 countries

    Sharay ANA Screen (CLIA)

    Device
    EU IVDD · Eu Ivd General ·C-Luminary Biotechnology Co., Ltd.·No longer on the market

    hybcell Bacteria DNA xB

    Device
    EU IVDD · Eu Ivd General ·Cube Dx GmbH·On the market·32 countries

    hybcell Fungi DNA xB

    Device
    EU IVDD · Eu Ivd General ·Cube Dx GmbH·On the market·32 countries

    hybcell Pathogens DNA xB

    Device
    EU IVDD · Eu Ivd General ·Cube Dx GmbH·On the market·32 countries

    GINA 500 + DNA purification

    Device
    EU IVDD · Eu Ivd General ·Cube Dx GmbH·On the market·32 countries

    DNA Prevention Test (v2)

    Device
    EU MDR · Eu Md Class 1 ·No longer on the market

    DNA GENOMIC PREPARATION DEVICES

    Device
    EU IVDR · Eu Ivd Class A ·Jiangsu CoWin Biotech Co., Ltd.·On the market

    DNA GENOMIC PREPARATION DEVICES

    Device
    EU IVDR · Eu Ivd Class A ·Jiangsu CoWin Biotech Co., Ltd.·On the market

    DNA GENOMIC PREPARATION DEVICES

    Device
    EU IVDR · Eu Ivd Class A ·Jiangsu CoWin Biotech Co., Ltd.·On the market

    DNA Slim Test (v2)

    Device
    EU MDR · Eu Md Class 1 ·No longer on the market