BEUDAMED
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    ARCHITECT FREE PSA MASTERCHECK, MODEL 6C07-05; ARCHITECT TITAL PSA MASTERCHECK, MODEL 6C06-05

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

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

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH FREE PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER

    VITROS CA 125 II Range Verifier

    FDA registration
    ORTHO-CLINICAL DIAGNOSTICS, INC.·1 product·🇺🇸 United States

    VITROS CA 125 II Range Verifier

    FDA registration
    Ortho-Clinical Diagnostics·1 product·🇬🇧 United Kingdom

    VITROS CA 125 II Range Verifier

    FDA registration
    ORTHO-CLINICAL DIAGNOSTICS, INC.·1 product·🇺🇸 United States

    VITROS CA 125 II Range Verifier

    FDA registration
    Ortho Clinical Diagnostics, K.K.·1 product·🇯🇵 Japan

    VITROS CA 125 II Range Verifier

    FDA registration
    Ortho-Clinical Diagnostics European Support Center·1 product·🇫🇷 France

    VITROS CA 125 II Range Verifier

    FDA registration
    Ortho Clinical Diagnostics·1 product·🇸🇬 Singapore

    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    FDA Pre-Market Approval
    FDA Class 2 ·TANDEM-R PSA IMMUNORADIOMETRIC ASSAY IMMUNOMETRIC TANDEM-E PSA IMMUNORADIOMETRIC ASSAY

    AFP AccuLite® CLIA Test System (Ref 1975-300A and 1975-300B)

    FDA registration
    MONOBIND, INC.·1 product·🇺🇸 United States

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

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM FREE PSA

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

    FDA Pre-Market Approval
    FDA Class 3 ·IMMULITE / IMMULITE 1000 AND IMMULITE 2000 FREE PSA ASSAYS

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

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ARCHITECT FREE PSA

    Access Hybritech PSA QC

    FDA UDI
    Beckman Coulter, Inc.·H628372091·The Access Hybritech PSA QC are tri-level contr...

    IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)

    FDA 510(k)
    FDA Class 2 ·Immunology

    ACCESS HYBRITECH PSA QC, MODEL 37209

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PACING SYSTEM ANALYZER PSA SCE-22

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FASTPACK TOTAL PSA METHOD VERIFICATION KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    IMMULITE PSA CONTROL MODULE, MODEL LPSCM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry