BEUDAMED
    10,000 results · 45ms · Sources: EU EUDAMED, US FDA

    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 MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER

    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 MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER

    Alinity

    FDA UDI
    Abbott Ireland Diagnostics·00380740153953·Alinity i BRAHMS PCT Reagent Kit 200 Tests

    Atellica IM BRAHMS PCT

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414246550·Procalcitonin (PCT) Atellica IM - RGT 100T

    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 MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT SYSTEM ON THE RAPTOR OTW DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY S

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·SIEMENS IMMULITE PSA AND THIRD GENERATION PSA ASSAYS ON THE IMMULITE, IMMULITE 1000, 2000 AND IMMULITE 2500 ANALYZERS

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·BX VELOCITY STENT WITH RAPTOR OVER-THE-WIRE DELIVERY SYSTEM, BX VELOCITY STENT ON RAPTORRAIL TX DELIVERY SYSTEM

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER

    On-Body Injector

    FDA classification
    FDA Class 2 ·On-Body Injector

    Hepatitis Viral B Dna Detection

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

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·BX VELOCITY BALLOON EXPANDABLE STENT WITH RAPTOR OTW DELIVERY SYSTEM AND BX VELOCITY STENT WITH HEPACOAT ON RAPTOR OTW

    Hepatitis Viral B Dna Detection

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

    Hepatitis Viral B Dna Detection

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

    Hepatitis Viral B Dna Detection

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

    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 601 IMMUNOASSAY ANALYZER