Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Alinity m HBV

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

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologuard

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 DNA Sample Preparation Kit, COBAS 4800 BRAF V600 MUTATION TEST

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·COBAS HPV TEST

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Epi proColon

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Epi proColon

Cancer-Related Germline Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·BRACAnalysis CDx

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·COBAS EGFR MUTATION TEST V2

Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)

FDA classification

FDA Class 3 ·Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)

Implanted Cerebellar Stimulator

FDA classification

FDA Class 3 ·Implanted Cerebellar Stimulator

Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce

FDA classification

FDA Class 3 ·Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce

Device, Antichoke, Suction

FDA classification

FDA Class 3 ·Device, Antichoke, Suction

Sterilizer, Endodontic Dry Heat

FDA classification

FDA Class 3 ·Sterilizer, Endodontic Dry Heat

Sterilizer, Glass Bead

FDA classification

FDA Class 3 ·Sterilizer, Glass Bead

Prosthesis, Testicle

FDA classification

FDA Class 3 ·Prosthesis, Testicle

Prosthesis, Testicular

FDA classification

FDA Class 3 ·Prosthesis, Testicular