Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·MODEL 515 NEONATAL MONIOTR

Radioimmunoassay, Thyroxine-Binding Globulin

FDA classification

FDA Class 2 ·Radioimmunoassay, Thyroxine-Binding Globulin

Electrode, Gel, Electrosurgical

FDA classification

FDA Class 2 ·Electrode, Gel, Electrosurgical

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

Jak2 Gene Mutation Detection Test

FDA classification

FDA Class 2 ·Jak2 Gene Mutation Detection Test

Setmelanotide Eligibility Gene Variant Detection System

FDA classification

FDA Class 2 ·Setmelanotide Eligibility Gene Variant Detection System

C. Difficile Toxin Gene Amplification Assay

FDA classification

FDA Class 2 ·C. Difficile Toxin Gene Amplification Assay

Complete Gene Expression Profiling Accessory Reagents

FDA classification

FDA Class 2 ·Complete Gene Expression Profiling Accessory Reagents

Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

FDA classification

FDA Class 2 ·Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers

Dissolvable Gel For Preventing Ureteral Stone Migration

FDA classification

FDA Class 2 ·Dissolvable Gel For Preventing Ureteral Stone Migration

Cardiac Allograft Gene Expression Profiling Test System

FDA classification

FDA Class 2 ·Cardiac Allograft Gene Expression Profiling Test System

Foam Or Gel Chemical Sterilant/High Level Disinfectant

FDA classification

FDA Class 2 ·Foam Or Gel Chemical Sterilant/High Level Disinfectant

Absorbable Gel For Intraoperative Use In Spine Surgery

FDA classification

FDA Class 2 ·Absorbable Gel For Intraoperative Use In Spine Surgery

Autosomal Recessive Carrier Screening Gene Mutation Detection System

FDA classification

FDA Class 2 ·Autosomal Recessive Carrier Screening Gene Mutation Detection System

Peripheral Blood Processing Device For Wound Management

FDA classification

FDA Class 2 ·Peripheral Blood Processing Device For Wound Management

System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

Analyzer, Medical Image

FDA classification

FDA Class 2 ·Analyzer, Medical Image

Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin

FDA classification

FDA Class 2 ·Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin

Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin

FDA classification

FDA Class 2 ·Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin

Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin

FDA classification

FDA Class 2 ·Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin