25 results · 45ms · Sources: EU EUDAMED, US FDA

Air-Conduction Hearing Aid Software

FDA classification
FDA Class 2 ·Air-Conduction Hearing Aid Software

Bcr/Abl1 Monitoring Test

FDA classification
FDA Class 2 ·Bcr/Abl1 Monitoring Test

Internal Polymerase Chain Reaction Control, Not Assay Specific

FDA classification
FDA Class 1 ·Internal Polymerase Chain Reaction Control, Not Assay Specific

Droplet Digital Pcr System

FDA classification
FDA Class 2 ·Droplet Digital Pcr System

Setter, Band, Orthodontic

FDA classification
FDA Class 1 ·Setter, Band, Orthodontic

Light Source, Photographic, Fiberoptic

FDA classification
FDA Class 2 ·Light Source, Photographic, Fiberoptic

Herpes Simplex Virus Nucleic Acid Amplification Assay

FDA classification
FDA Class 2 ·Herpes Simplex Virus Nucleic Acid Amplification Assay

Sars-Cov-2 Serology Test

FDA classification
FDA Class 2 ·Sars-Cov-2 Serology Test

System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test

FDA classification
FDA Class 2 ·System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test

Non-Sars Coronavirus Multiplex Nucleic Acid Assay

FDA classification
FDA Class 2 ·Non-Sars Coronavirus Multiplex Nucleic Acid Assay

Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

FDA classification
FDA Class 2 ·Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

Test, Factor V Leiden Mutations, Genomic Dna Pcr

FDA classification
FDA Class 2 ·Test, Factor V Leiden Mutations, Genomic Dna Pcr

Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

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

Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation

FDA classification
FDA Not Classified ·Test, Cell Mediated Immune Response, Liver And Small Bowel Transplant/Transplantation

Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

FDA classification
FDA Class 2 ·Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

Leukemia Translocation Panel Multiplex Test

FDA classification
FDA Not Classified ·Leukemia Translocation Panel Multiplex Test

Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

FDA classification
FDA Class 2 ·Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set

Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis

FDA classification
FDA Not Classified ·Ngs Whole Genome Sequencing For Sars-Cov-2 Genetic Analysis

Cardiac Allograft Gene Expression Profiling Test System

FDA classification
FDA Class 2 ·Cardiac Allograft Gene Expression Profiling Test System

Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection

FDA classification
FDA Class 3 ·Rt-Pcr Multigene Expression Test, Sentinel Lymph Node, Cancer Metastasis Detection