87 results · 39ms · Sources: EU EUDAMED, US FDA

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