339 results · 42ms · Sources: EU EUDAMED, US FDA

Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

FDA classification
FDA Class 2 ·Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment

Antibodies, Anti-Actin, Anti-Smooth Muscle

FDA classification
FDA Class 2 ·Antibodies, Anti-Actin, Anti-Smooth Muscle

Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

FDA classification
FDA Class 3 ·Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer)

FDA classification
FDA Class 2 ·Kit, Test For Nuclear Matrix (Numa) Protein (For Monitoring And Management Of Colorectal Cancer)

System, Test, Hypersensitivity Pneumonitis

FDA classification
FDA Class 2 ·System, Test, Hypersensitivity Pneumonitis

Lactic Dehydrogenase, Antigen, Antiserum, Control

FDA classification
FDA Class 1 ·Lactic Dehydrogenase, Antigen, Antiserum, Control

Method, Nephelometric, Immunoglobulins (G, A, M)

FDA classification
FDA Class 2 ·Method, Nephelometric, Immunoglobulins (G, A, M)

Immunoglobulin A Kappa Heavy & Light Chain Combined

FDA classification
FDA Class 2 ·Immunoglobulin A Kappa Heavy & Light Chain Combined

System, Test, Thyroid Autoantibody

FDA classification
FDA Class 2 ·System, Test, Thyroid Autoantibody

Research Use Only/Immunology Devices

FDA classification
FDA Not Classified ·Research Use Only/Immunology Devices

Haptoglobin, Fitc, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Haptoglobin, Fitc, Antigen, Antiserum, Control

Test, Donor, Syphilis, Antigens, Treponemal

FDA classification
FDA Class 2 ·Test, Donor, Syphilis, Antigens, Treponemal

Kappa, Rhodamine, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Kappa, Rhodamine, Antigen, Antiserum, Control

Iga, Ferritin, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Iga, Ferritin, Antigen, Antiserum, Control

Kit, Test, Quality Control For Endotoxin

FDA classification
FDA Not Classified ·Kit, Test, Quality Control For Endotoxin

Igm, Ferritin, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Igm, Ferritin, Antigen, Antiserum, Control

Anti-Ss-A 52 Autoantibodies

FDA classification
FDA Class 2 ·Anti-Ss-A 52 Autoantibodies

Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

FDA classification
FDA Class 2 ·Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)

Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease

FDA classification
FDA Class 2 ·Diagnostic Software, K-Nearest Neighbor Algorithm, Autoimmune Disease

Igd, Rhodamine, Antigen, Antiserum, Control

FDA classification
FDA Class 2 ·Igd, Rhodamine, Antigen, Antiserum, Control