19 results · 20ms · 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

Droplet Digital Pcr System

FDA classification
FDA Class 2 ·Droplet Digital Pcr System

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 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

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

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

Cardiac Allograft Gene Expression Profiling Test System

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

Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

FDA classification
FDA Class 2 ·Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

Dna Genetic Analyzer

FDA classification
FDA Class 2 ·Dna Genetic Analyzer

Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

FDA classification
FDA Class 2 ·Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

FDA classification
FDA Class 2 ·Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

FDA classification
FDA Class 2 ·Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings