Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Abbott RealTime IDH1, Abbott RealTime IDH1 Amplification Reagent Kit, Abbott RealTime IDH1 Control Kit, Abbott RealTime

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® BRAF V600 Mutation Test

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·ROCHE COBAS 4800 BRAF V600 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 ·QIAGEN THERASCREEN EGFR RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas DNA Sample Preparation Kit, Roche cobas 4800 BRAF V600 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 ·LeukoStrat CDx FLT3 Mutation Assay

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas KRAS Mutation Test, Roche cobas DNA Sample Preparation Kit

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA Pre-Market Approval

FDA Class 3 ·Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor , Eversense Insertion Tools, Evers

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat® CDx FL T3 Mutation Assay

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·THERASCEEN EGFR RGQ PCR KIT

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST