BEUDAMED
    10,000 results · 50ms · Sources: EU EUDAMED, US FDA

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·BX VELOCITY BALLOON-EXPANDABLE STENT WITH RAPTOR OVER THE WIRE DELIVERY SYSTEM/BX VELOCITY WITH HEPACOAT ON RAPTOR STENT

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON THE ROCHE COBAS E 411 IMMUNOASSAY ANALYZER

    be-on-market GmbH

    Authorized representative
    🇩🇪 Germany·3 Manufacturers·2 Devices

    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

    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

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA

    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

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA

    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

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIOH SV STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYST SV OTW), AND PC C)

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Roche COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 and COBAS TaqMan HBV Test for use on the High Pure System

    Scale, Stand-On, Patient

    FDA classification
    FDA Class 1 ·Scale, Stand-On, Patient

    ARCHITECT

    FDA UDI
    Abbott GmbH·00380740139049·ARCHITECT B.R.A.H.M.S PCT Reagent Kit

    ARCHITECT

    FDA UDI
    Abbott GmbH·00380740139032·ARCHITECT B.R.A.H.M.S PCT Reagent Kit

    ARCHITECT

    FDA UDI
    Abbott GmbH·00380740138912·ARCHITECT B.R.A.H.M.S PCT Controls

    ARCHITECT

    FDA UDI
    Abbott GmbH·00380740138905·ARCHITECT B.R.A.H.M.S PCT Calibrators