BEUDAMED
    210 results · 37ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    Qualitative And Quantitative Hepatitis B Virus Antibody Assays

    FDA Pre-Market Approval
    FDA Class 2 ·IMMULITE 2000 XPI ANTI-HBC IMG

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·IMMULITE 2000 Anti HBc IgM

    FDA Pre-Market Approval
    IMMULITE® 2000 Anti-HBc IgM

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·IMMULITE, IMMULITE 1000 ANTI-HBC AND IMMULITE 2000 ANTI-HBC

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC IGM

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·ANTI-HBC IGM

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·IMMULITE 2000 Anti-HBc IgM

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC IGM

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·ANTI-HBCM IMMULITE ASSAY

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·IMMULITE 2000 Anti-HBcM

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·IMMULITE® 2000 Anti-HBc IgM

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·ANTI-HBCM IMMULITE SUBSTRATE REAGENT

    Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

    FDA Pre-Market Approval
    FDA Class 2 ·IMMULITE 2000/2000 XPi Anti-HBc IgM

    IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions Diagnostics·April 9, 2014

    Atos Medical

    FDA UDI
    ATOS MEDICAL INC.·00817126020702·2010-053 Laryngectomy Pulmonary Kit with Standa...

    CastleLoc Pectus Bar System Instrument Set

    FDA UDI
    L&K BIOMED CO. ,LTD.·08809986466372·Introducer Bar 300mm

    MedStream

    FDA UDI
    MEDICAL SPECIALTIES DISTRIBUTORS, LLC·00842472101096·DRESSING CHANGE KIT - CUSTOM

    Atos Medical

    FDA UDI
    ATOS MEDICAL INC.·00817126020542·Custom Laryngectomy Pulmonary Kit 12/55 With Pr...