BEUDAMED
    1,232 results · 21ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS TOTAL PSA (TPSA) TEST SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys Anti-HBc II, PreciControl Anti-HBc

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

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys Anti-HBc IgM

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

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys total PSA

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS HBV TEST

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0

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

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys Anti-HBc II

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

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys Anti-HBc IgM

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS FREE PSA (FPSA) TEST SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys Anti-HBc IgM

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

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys Anti-HBs

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

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys HBeAg

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS HPV TEST

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS TAQMAN HBV TEST

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

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys HBsAg Immunoassay

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS AMPLIPREP/COBAS TAQMAN HBV V2.0

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS AmpliPrep/COBAS TaqMan HBV Test

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS AmpliPrep/COBAS TaqMan HBV, v2.0

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST