333 results · 43ms · Sources: EU EUDAMED, US FDA

Coronary Artery Disease Risk Indicator From Acoustic Heart Signals

FDA classification
FDA Class 2 ·Coronary Artery Disease Risk Indicator From Acoustic Heart Signals

11-Dehydro Thromboxane B2 Kit, Urinary

FDA classification
FDA Class 2 ·11-Dehydro Thromboxane B2 Kit, Urinary

Bacteriophage And Controls, B. Anthracis Lysis

FDA classification
FDA Class 2 ·Bacteriophage And Controls, B. Anthracis Lysis

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA classification
FDA Class 2 ·System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

FDA classification
FDA Class 2 ·Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System

Breast Milk Macronutrients Test System

FDA classification
FDA Class 2 ·Breast Milk Macronutrients Test System

Immunohistochemistry Assay, Antibody, Ki-67

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Ki-67

Anti-Phospholipase A2 Receptor

FDA classification
FDA Class 2 ·Anti-Phospholipase A2 Receptor

Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma

FDA classification
Cancer Monitoring Test System, Soluble Mesothelin-Related Peptides, Epithelioid/Biphasic Mesothelioma

Antigen, Cartilage Oligomeric Matrix Protein (Comp)

FDA classification
FDA Class 2 ·Antigen, Cartilage Oligomeric Matrix Protein (Comp)

Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria

FDA classification
FDA Not Classified ·Enzyme Linked Immunosorbent Assay For The Detection Of Lipoarabinomannan Antigen Of Mycobacteria

Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents

FDA classification
FDA Not Classified ·Rickettsia Spp. (Spotted Fever Group Or Typhus Group) Serological Reagents

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA classification
FDA Class 3 ·Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

Biliary Stent, Drain, And Dilator Accessories

FDA classification
FDA Class 1 ·Biliary Stent, Drain, And Dilator Accessories

Brain Trauma Assessment Test

FDA classification
FDA Class 2 ·Brain Trauma Assessment Test

Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

FDA classification
FDA Class 2 ·Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System

Phase-Changing Fiducial Marker For Radiation Therapy

FDA classification
FDA Class 2 ·Phase-Changing Fiducial Marker For Radiation Therapy

Procalcitonin Assay

FDA classification
FDA Class 2 ·Procalcitonin Assay

Yersinia Spp. Reagents

FDA classification
FDA Unclassified ·Yersinia Spp. Reagents