4,176 results
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76ms
·
Sources: EU EUDAMED, US FDA
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT TOTAL PSA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·CEA-EIA DIAGNOSTIC TEST KIT
FDA Pre-Market Approval
ARCHITECT CORE / Alinity i Anti-HBc
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·AXSYM ANTI-HCV (LN 5C36)
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
FDA Pre-Market Approval
FDA Class 2
·ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE-M
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT FREE PSA
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·ABBOTT AXSYM CEA (LIST 7A47)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE-M
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·ABBOTT CEA-EIA
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ABBOTT HBE (RDNA) EIA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE-M (LN 6L23)
Hepatitis A Test (Antibody And Igm Antibody)
FDA Pre-Market Approval
FDA Class 2
·HAVAB-M DIAGNOSTIC KIT
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT Total PSA Reagent Kit, Alinity i Total PSA Reagent Kit
Hepatitis A Test (Antibody And Igm Antibody)
FDA Pre-Market Approval
FDA Class 2
·HAVAB-M EIA
Hepatitis A Test (Antibody And Igm Antibody)
FDA Pre-Market Approval
FDA Class 2
·HAVAB
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ABBOTT IMX FREE PSA
FDA Pre-Market Approval
ARCHITECT Total PSA / Alinity i Total PSA