935 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·IMMULITE 2000 HBS AG CONFIRMATORY KIT
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
FDA Pre-Market Approval
FDA Class 3
·PLASMAFLO OP-05W (A)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·IMMULITE 2000 Anti-HBc
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·IMMULITE/ IMMULITE 1000 AND IMMULITE 2000 HBSAG KITS.
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
FDA Pre-Market Approval
FDA Class 3
·Scoreflex NC Scoring PTCA Catheter
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·IMMULITE/IMMULITE 1000 & IMMULITE 2000 HBSAG & IMMULITE/IMMULITE 1000/IMMULITE 2000 HBSAG CONFIRMATORY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·IMMULITE 2000/2000 XPi Anti-HBc
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ANTI-HBS IMMULITE SUBSTRATE REAGENT
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·HBSAG IMMULITE SUBSTRATE REAGENT
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
FDA Pre-Market Approval
FDA Class 3
·Plasmaflo OP-05W(A)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·HBSAG
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
FDA Pre-Market Approval
FDA Class 3
·Scoreflex NC Scoring PTCA Catheter
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ANTI-HBCM IMMULITE ASSAY
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
FDA Pre-Market Approval
FDA Class 3
·Scoreflex NC Scoring PTCA Catheter
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·IMMULITE / IMMULITE 1000 HBSAG & IMMULITE 2000 HBSAG
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ANTI-HBC IGM
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
FDA Pre-Market Approval
FDA Class 3
·PLASMAFLO OP-05W (A)
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
FDA Pre-Market Approval
FDA Class 3
·PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR
Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
FDA Pre-Market Approval
FDA Class 3
·Plasmaflo OP-05W(A)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ANTI-HBS