1,113 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Cobas EGFR Mutation Test and Cobas EGFR Mutation Test v2
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys Anti-HBs II
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·COBAS EGFR MUTATION TEST
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·COBAS EGFR MUTATION TEST
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys Anti-HBs II, PreciControl Anti-HBs
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·cobas EGFR Mutation Test v2
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·cobas EGFR Mutation Test and cobas EGFR Mutation Test v2
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·cobas EGFR Mutation Test v2
Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
FDA Pre-Market Approval
FDA Class 3
·DIMENSION TPSA FLEX REAGENT CARTRIDGE
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·cobas® EGFR Mutation Test
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·cobas EGFR Mutation Test and cobas EGFR Mutation Test v2
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·COBAS EGFR MUTATION TEST
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·COBAS EGFR MUTATION TEST