Somatic Gene Mutation Detection System

FDA Pre-Market Approval

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

Pediatric Esophageal Atresia Anastomosis Device

FDA classification

FDA Class 3 ·Pediatric Esophageal Atresia Anastomosis Device

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA classification

FDA Class 3 ·Prosthesis, Ankle, Uncemented, Non-Constrained

Kit, Assay, Estrogen Receptor

FDA classification

FDA Class 3 ·Kit, Assay, Estrogen Receptor

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA classification

FDA Class 3 ·Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

Immunocytochemistry Assay, P16/Ki-67

FDA classification

FDA Class 3 ·Immunocytochemistry Assay, P16/Ki-67

Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor

FDA classification

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

Immunohistochemistry Assay, Antibody, Claudin 18

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Claudin 18

Immunohistochemistry Assay, Antibody, Folr1

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Folr1

Immunohistochemistry Antibody Assay, C-Kit

FDA classification

FDA Class 3 ·Immunohistochemistry Antibody Assay, C-Kit

Immunohistochemistry Assay, Antibody, Met

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Met

Kit, Assay, Progesterone Receptor

FDA classification

FDA Class 3 ·Kit, Assay, Progesterone Receptor

Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software

Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

FDA classification

FDA Class 3 ·Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling

Generator, Pulsatile Flow, Cardiopulmonary Bypass

FDA classification

FDA Class 3 ·Generator, Pulsatile Flow, Cardiopulmonary Bypass

Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

FDA classification

FDA Class 3 ·Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon System