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, Epidermal Growth Factor Receptor

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA classification

FDA Class 3 ·System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

FDA classification

FDA Class 3 ·System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection

Kit, Dna Detection, Human Papillomavirus

FDA classification

FDA Class 3 ·Kit, Dna Detection, Human Papillomavirus

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA classification

FDA Class 3 ·Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA classification

FDA Class 3 ·Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA classification

FDA Class 3 ·Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

Device, Oxidase Test For Gonorrhea

FDA classification

FDA Class 3 ·Device, Oxidase Test For Gonorrhea

Gonococcal Antibody Tests

FDA classification

FDA Class 3 ·Gonococcal Antibody Tests

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

FDA classification

FDA Class 3 ·Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg

Hiv Self-Tests

FDA classification

FDA Class 3 ·Hiv Self-Tests

Test, Anti-Tumor Cell Susceptibility

FDA classification

FDA Class 3 ·Test, Anti-Tumor Cell Susceptibility

Hepatitis Delta Serological Reagents

FDA classification

FDA Class 3 ·Hepatitis Delta Serological Reagents

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

Immunohistochemistry Antibody Assay, C-Kit

FDA classification

FDA Class 3 ·Immunohistochemistry Antibody Assay, C-Kit

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 670G System