6 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
·VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK/CALIBRATORS
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 v2
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 v2, Cobas DNA and cfDNA Sample Preparation Kit