313 results
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19ms
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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 IMMUNOASSAY
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·IMMULITE® /IMMULITE® 1000 PSA, IMMULITE® 2000 PSA and IMMULITE® /IMMULITE® 1000 Third Generation PSA
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH PSA ASSAY
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·Immulite/Immulite 1000 PSA/Immulite 2000 PSA
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·AXSYM TOTAL PSA & ARCHITECT TOTAL PSA
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR XP PSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE)
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT TOTAL PSA (LN 6C06)
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·Dimension Vista TPSA Flex reagent cartridge
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT TOTAL PSA
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT TOTAL PSA
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSION VISTA TPSA ASSAY
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·TPSA FLEX REAGENT
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSION TPSA FLEX REAGENT CARTRIGE AND DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ACCESS PSA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech PSA Reagents on the Access Immunoassay Systems
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ACCESS HYBRITECH PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·Access Hybritech PSA Reagents on the Access Immunoassay Systems
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSION TPSA FLEX REAGENT CARTRIDGE
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE FOR USE ON THE DIMENSION VISTA 500 SYSTEM