BEUDAMED
    973 results · 26ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 2 ×

    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 TaqMan HCV Test, v2.0 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure System

    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 TaqMan HCV Test, v2.0 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure System

    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 TaqMan HCV Test, v2.0 and COBAS TaqMan HCV Test, v2.0 for use on the High Pure System

    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 TaqMan HCV Test, v2.0 and COBAS TaqMan HCV TEst, v2.0 for use on the High Pure System

    Access PCT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

    FDA 510(k)
    FDA Class 2 ·Microbiology

    DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Access PCT, Access PCT Calibrators

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

    FDA classification
    FDA Class 2 ·Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

    Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

    FDA classification
    FDA Class 2 ·Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

    Device For Sleep Apnea Testing Based On Mandibular Movement

    FDA classification
    FDA Class 2 ·Device For Sleep Apnea Testing Based On Mandibular Movement

    Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

    FDA classification
    FDA Class 2 ·Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer

    Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission

    FDA classification
    FDA Class 2 ·Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission