BEUDAMED
    10,000 results · 96ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 2 ×

    cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BioFire COVID-19 Test 2

    FDA 510(k)
    FDA Class 2 ·Microbiology

    cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    BioFire COVID-19 Test 2

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Aptima SARS-CoV-2 Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Simplexa COVID-19 Direct

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·AXSYM ANTI-HCV

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·AXSYM ANTI-HCV

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ARCHITECT ANTI-HCV

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & CALIBRATOR

    Notal Vision Home Optical Coherence Tomography (OCT) System

    FDA 510(k)
    FDA Class 2 ·Ophthalmic