BEUDAMED
    1,546 results · 43ms · Sources: EU EUDAMED, US FDA

    Mouse anti-AFP (ZSA06) Concentrate

    FDA UDI
    LIFE TECHNOLOGIES CORPORATION·10190302007832·

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT AXSYM AFP

    CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System

    FDA 510(k)
    FDA Class 2 ·Radiology

    ST AIA-PACK AFP ENZYME IMMUNOASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    ROCHE DIAGNOSTICS ELECSYS AFP CALSET II

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ARCHITECH AFP MASTERCHECK, MODEL 6C01-05

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VITROS IMMUNODIAGNOSTIC PRODUCTS AFP RANGE VERIFIERS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AFP CARDIAC PACING SYSTEM MODEL 283

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA CENTAUR AFP REAGENTS AND CALIBRATORS

    Sharay AFP (CLIA)

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

    CLIA AFP Control

    Device
    EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

    CLIA AFP Calibrator

    Device
    EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·On the market

    AFP CLIA Microparticles

    Device
    EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

    AFP CLIA Microparticles

    Device
    EU IVDR · Eu Ivd Class C ·Autobio Diagnostics Co., Ltd.·On the market·3 countries

    Access AFP (Calibrators)

    Device
    EU IVDR · Eu Ivd Class C ·Beckman Coulter Inc.·On the market·32 countries

    AFP FIA Kit

    Device
    EU IVDD · Eu Ivd General ·Shenzhen Zijian Biotechnology Co., Ltd·On the market

    AFP IRMA KIT

    Device
    EU IVDR · Eu Ivd Class C ·IMMUNOTECH s.r.o.·On the market·17 countries

    Access AFP Calibrators

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Beckman Coulter Inc.·On the market·32 countries

    Access AFP Diluent

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·Beckman Coulter Inc.·On the market·32 countries