19 results · 20ms · Sources: EU EUDAMED, US FDA

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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

Setter, Band, Orthodontic

FDA classification
FDA Class 1 ·Setter, Band, Orthodontic

Light Source, Photographic, Fiberoptic

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

Sars-Cov-2 Serology Test

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

Non-Sars Coronavirus Multiplex Nucleic Acid Assay

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

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, Factor Ii G20210a Mutations, Genomic Dna Pcr

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

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

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

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

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

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

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

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

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