106 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm
FDA Pre-Market Approval
FDA Class 3
·BIOTRIN PARVOVIRUS IGM EIA (V619IMUS)
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON XL MUREX Anti-HBc, LIAISON MUREX Control Anti-HBc
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·AXSYM CORE 2.0 AND AXSYM CORE 2.0 CONTROLS
Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
FDA classification
FDA Class 3
·Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg
Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
FDA Pre-Market Approval
FDA Class 3
·DIMENSION FPSA FLEX REAGENT CARTRIDGE
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR