Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP 2000 SYSTEM

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PREPSTAIN SYSTEM

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·COLOGUARD

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

FDA Pre-Market Approval

FDA Class 3 ·FoundationOne®CDx (F1CDx)

Immunohistochemistry Assay, Antibody, Met

FDA Pre-Market Approval

FDA Class 3 ·VENTANA MET (SP44) RxDx Assay

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1(SP142) CDX ASSAY

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS EGFR MUTATION TEST

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

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target 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

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·HER2 CISH PHARMDX KIT

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·ColoSense

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

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·INSITE HER-2/NEU KIT

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·INFORM HER2 Dual ISH DNA Probe Cocktail

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM

Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer

FDA Pre-Market Approval

FDA Class 3 ·HER2 CISH PHARMADX KIT

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·Hercep Test