2,207 results
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43ms
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Sources: EU EUDAMED, US FDA
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·Cobas CMV
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·Cobas TaqMan HCV Test, v2.0
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ABBOTT REAL TIME HBV CALIBRATOR KIT
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·COBAS KRAS MUTATION TEST
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·therascreen BRAF V600E RGQ PCR Kit
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Roche cobas KRAS Mutation Test /Roche cobas DNA Sample Preparation Kit
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Roche cobas EGFR Mutation Test, Roche cobas DNA Sample Preparation Kit
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·CRCDx RAS Mutation Detection Assay Kit
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·THxID BRAF assay kit
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 KRAS Mutation Test
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·THXID BRAF KIT
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·therascreen FGFR RGQ RT-PCR Kit
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·THXID-BRAF
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·Abbott RealTime IDH1
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·QIAGEN therascreen® KRAS RGQ PCR Kit
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
·LeukoStrat CDx FLT3 Mutation Assay