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

Continuous Measurement Thermometer

FDA classification
FDA Class 2 ·Continuous Measurement Thermometer

Test, Immunoassay, Biosensor, Hcg

FDA classification
FDA Class 2 ·Test, Immunoassay, Biosensor, Hcg

Immunohistochemical Assay, Helicobacter Pylori

FDA classification
FDA Class 1 ·Immunohistochemical Assay, Helicobacter Pylori

Test, Donor, Syphilis, Antigens, Treponemal

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

Test, Syphilis, Treponemal

FDA classification
FDA Not Classified ·Test, Syphilis, Treponemal

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

Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies

FDA classification
FDA Not Classified ·Test, Qualitative, Detection Of Dengue Igm And Igg Antibodies

System, Identification, Hepatitis B Antigen

FDA classification
FDA Class 3 ·System, Identification, Hepatitis B Antigen

Radioimmunoassay, Immunoglobulins (D, E)

FDA classification
FDA Class 2 ·Radioimmunoassay, Immunoglobulins (D, E)

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA classification
FDA Class 2 ·Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

Dengue Virus Antigen Assay

FDA classification
FDA Class 2 ·Dengue Virus Antigen Assay

Respiratory Syncytial Virus, Antigen, Antibody, Ifa

FDA classification
FDA Class 1 ·Respiratory Syncytial Virus, Antigen, Antibody, Ifa

Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

FDA classification
FDA Not Classified ·Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

Respiratory Syncytial Virus - Elisa

FDA classification
FDA Class 1 ·Respiratory Syncytial Virus - Elisa

Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

FDA classification
FDA Class 2 ·Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

Influenza A And Influenza B Multiplex Nucleic Acid Assay

FDA classification
FDA Class 2 ·Influenza A And Influenza B Multiplex Nucleic Acid Assay

Radioimmunoassay (Two-Site Solid Phase), Ferritin

FDA classification
FDA Class 2 ·Radioimmunoassay (Two-Site Solid Phase), Ferritin

Hepatitis A Test (Antibody And Igm Antibody)

FDA classification
FDA Class 2 ·Hepatitis A Test (Antibody And Igm Antibody)

Fibrin Split Products

FDA classification
FDA Class 2 ·Fibrin Split Products

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)