87 results
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39ms
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Sources: EU EUDAMED, US FDA
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FDA Classification
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Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
FDA classification
FDA Class 2
·Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (Bk) Dna
Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
FDA classification
FDA Class 2
·Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
ß-Glucocerebrosidase (Gba) Newborn Screening Test System
FDA classification
FDA Class 2
·ß-Glucocerebrosidase (Gba) Newborn Screening Test System
Oximeter, Reprocessed
FDA classification
FDA Class 2
·Oximeter, Reprocessed
System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
FDA classification
FDA Class 2
·System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations
Lynch Syndrome Test System
FDA classification
FDA Class 2
·Lynch Syndrome Test System
Nucleic Acid Quantitation Kit
FDA classification
FDA Class 1
·Nucleic Acid Quantitation Kit
Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
FDA classification
FDA Class 3
·Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment
FDA classification
FDA Class 2
·Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment
Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
FDA classification
FDA Class 2
·Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System
Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
FDA classification
FDA Class 2
·Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
Drug Metabolizing Enzyme Genotyping Systems
FDA classification
FDA Class 2
·Drug Metabolizing Enzyme Genotyping Systems
Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies
FDA classification
FDA Class 2
·Dna-Based Test For Minimal Residual Disease For Hematologic Malignancies
Braf Mutation Kit
FDA classification
FDA Not Classified
·Braf Mutation Kit
Assay, Proliferation, In Vitro, T Lymphocyte
FDA classification
FDA Class 2
·Assay, Proliferation, In Vitro, T Lymphocyte
Reagents For Molecular Diagnostic Test Systems
FDA classification
FDA Class 1
·Reagents For Molecular Diagnostic Test Systems
Neurologic Disease Risk Assessment Molecular Test
FDA classification
FDA Class 2
·Neurologic Disease Risk Assessment Molecular Test
System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
FDA classification
FDA Class 2
·System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen
Genetic Variant Detection And Health Risk Assessment System
FDA classification
FDA Class 2
·Genetic Variant Detection And Health Risk Assessment System
Spinal Muscular Atrophy Newborn Screening Test System
FDA classification
FDA Class 2
·Spinal Muscular Atrophy Newborn Screening Test System