1,598 results · 23ms · Sources: EU EUDAMED, US FDA

Antibodies, Outer-Membrane Proteins

FDA classification
FDA Class 2 ·Antibodies, Outer-Membrane Proteins

Galectin-3 In Vitro Diagnostic Assay

FDA classification
FDA Class 2 ·Galectin-3 In Vitro Diagnostic Assay

Sirolimus Test System

FDA classification
FDA Class 2 ·Sirolimus Test System

Deformability Cytometry For Sepsis Risk Assessment

FDA classification
FDA Class 2 ·Deformability Cytometry For Sepsis Risk Assessment

ß-Galactocerebrosidase (Galc) Newborn Screening Test System

FDA classification
FDA Class 2 ·ß-Galactocerebrosidase (Galc) Newborn Screening Test System

Influenza A Virus Subtype Differentiation Nucleic Acid Assay

FDA classification
FDA Class 2 ·Influenza A Virus Subtype Differentiation Nucleic Acid Assay

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

FDA classification
FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

Automated Digital Image Manual Interpretation Microscope

FDA classification
FDA Class 2 ·Automated Digital Image Manual Interpretation Microscope

Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection

FDA classification
FDA Class 2 ·Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection

Lateral Flow Immunochromatography Assay For Host Infection Biomarkers

FDA classification
FDA Class 2 ·Lateral Flow Immunochromatography Assay For Host Infection Biomarkers

Novel Influenza A Virus, A/H5 Ns1 Protein

FDA classification
FDA Class 2 ·Novel Influenza A Virus, A/H5 Ns1 Protein

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

Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.

FDA classification
FDA Class 2 ·Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.

Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

FDA classification
FDA Class 2 ·Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin

FDA classification
FDA Class 2 ·Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin

Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin

FDA classification
FDA Class 2 ·Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin

Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin

FDA classification
FDA Class 2 ·Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Kanamycin

Acid-Sphingomyelinase (Asm) Newborn Screening Test System

FDA classification
FDA Class 2 ·Acid-Sphingomyelinase (Asm) Newborn Screening Test System

Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

FDA classification
FDA Class 2 ·Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

Infliximab Test System

FDA classification
FDA Class 2 ·Infliximab Test System