System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

FDA classification

FDA Class 2 ·System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

FDA classification

FDA Class 2 ·Joint Biological Agent Identification And Diagnostic System (Jbaids) Tularemia Detection Kit

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

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

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·APTIMA HCV QUANT DX ASSAY

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

Assay, Proliferation, In Vitro, T Lymphocyte

FDA classification

FDA Class 2 ·Assay, Proliferation, In Vitro, T Lymphocyte

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

Autosomal Recessive Carrier Screening Gene Mutation Detection System

FDA classification

FDA Class 2 ·Autosomal Recessive Carrier Screening Gene Mutation Detection System