Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·cobas EGFR MUTATION TEST v2

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne CDx

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

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

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·Cobas EGFR Mutation Test v2, Cobas DNA and cfDNA Sample Preparation Kit

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Test System, For Drugs Of Abuse

FDA classification

FDA Class 3 ·Test System, For Drugs Of Abuse

Paraquat Assay

FDA classification

FDA Class 3 ·Paraquat Assay

Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

FDA classification

FDA Class 3 ·Opioid Use Disorder Genetic Risk Variant Detection System And Collection Kit

Gastric Emptying Breath Test

FDA classification

FDA Class 3 ·Gastric Emptying Breath Test

Placental Alpha Microglobulin-1 Immunoassay

FDA classification

FDA Class 3 ·Placental Alpha Microglobulin-1 Immunoassay