4,176 results
·
72ms
·
Sources: EU EUDAMED, US FDA
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
·ARCHITECH CORE
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
FDA Pre-Market Approval
FDA Class 2
·ABBOTT AXSYM AFP (LIST 7A48)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
FDA Pre-Market Approval
FDA Class 2
·ABBOTT AFP-EIA DIAGNOSTIC KIT FOR CANCER
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
Kit, Test, Alpha-Fetoprotein For Neural Tube Defects
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AFP (LN 3P36)
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT Free PSA, Alinity i Free PSA
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
FDA Pre-Market Approval
FDA Class 2
·ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·ABBOTT CEA-RIA MONOCLONAL
Hepatitis A Test (Antibody And Igm Antibody)
FDA Pre-Market Approval
FDA Class 2
·AXSYM HAVAB 2.0
Kit, Test,Alpha-Fetoprotein For Testicular Cancer
FDA Pre-Market Approval
FDA Class 2
·ABBOTT AXSYM AFP
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT FREE PSA
FDA Pre-Market Approval
ARCHITECT HBsAg Qualitative / HBsAg Qualitative Confirmatory, Alinity i HBsAg Qualitative II / HBsAg Qualitative II Conf
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBsAg Qualitative/Confirmatory/Alinity HBsAg Qualitative II/Confirmatory
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT FREE PSA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBSAG QUALITATIVE, QUALITATIVE CONFIRMATORY, CONFIRMATORY MANUAL DILUENT, CALIBRATORS, AND CONTROLS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE REAGENT KIT, ARCHITECT CORE CALIBRATOR AND ARCHITECT CORE CONTROLS
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
FDA Pre-Market Approval
FDA Class 2
·ANTIMICROBIAL SUSCEPTABILITY TEST SYSTEM