BEUDAMED
    4,549 results · 43ms · Sources: EU EUDAMED, US FDA

    Antigen(Complexed),Prostate Specific,(Cpsa)

    FDA Pre-Market Approval
    FDA Class 3 ·Adiva Centaur Complexed PSA (cPSA) Immunoassay and Atellica IM cPSA Immunoassay

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

    FDA Pre-Market Approval
    FDA Class 3 ·IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2500 PSA & 3RD GENERATIONPSA

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·MULTI-LINK 8, MULTI-LINK 8 SV/LL CORONARY STENT SYSTEMS

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

    FDA Pre-Market Approval
    FDA Class 3 ·IMMULITE, IMMULITE 1000, IMMULITE 2000, and IMMULITE 2500 3rd gen PSA

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

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS FREE PSA TEST SYSTEM ON COBAS E 601 IMMUNOASSAY ANALYZER

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

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS TOTAL PSA TEST SYSTEM ON COBAS E 601 IMMUNOASSAY ANALYZER

    Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

    FDA classification
    FDA Class 2 ·Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2

    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 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM

    HSV 1/2 IgM Rapid Test

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Hangzhou Genesis Biodetection and Biocontrol Co., Ltd.·1 device

    Malaria P.f/P.v Antigen Rapid Test

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Shanghai Zymetas Medtech Co., Ltd·1 device

    Malaria P.f/P.v Antigen Rapid Test

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Shanghai Zymetas Medtech Co., Ltd·1 device

    Malaria P.f/P.v Antigen Rapid Test

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Shanghai Zymetas Medtech Co., Ltd·1 device

    Malaria P.f. / P.v. Rapid Test Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·1 device

    Malaria P.f/P.v Antigen Rapid Test

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Xiamen Biotime Biotechnology Co., Ltd.·1 device

    Peripheral Intravenous (Piv) Infiltration Monitor

    FDA classification
    FDA Class 2 ·Peripheral Intravenous (Piv) Infiltration Monitor

    HSV-1 IgG/IgM Rapid Test Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·1 device

    HSV-2 IgG/IgM Rapid Test Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·1 device

    Malaria P.f. / P.v. Rapid Test Kit (FIA)

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Vitrosens Biyoteknoloji Anonim Şirketi·1 device

    HSV-2 IgG Antibody Chemiluminescent Immunoassay Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device

    HSV-2 IgG Antibody Chemiluminescent Immunoassay Kit

    Basic UDI-DI
    EU IVDD · Eu Ivd General ·Maccura Biotechnology Co., Ltd. ·1 device