159 results · 40ms · Sources: EU EUDAMED, US FDA

Cancer-Related Germline Gene Mutation Detection System

FDA classification
FDA Class 3 ·Cancer-Related Germline Gene Mutation Detection System

Biological Sterilization Process Indicator With Recombinant-Dna Plasmid

FDA classification
FDA Class 2 ·Biological Sterilization Process Indicator With Recombinant-Dna Plasmid

Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

FDA classification
FDA Class 2 ·Herpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA classification
FDA Class 3 ·System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

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

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

Somatic Gene Mutation Detection System

FDA classification
FDA Class 3 ·Somatic Gene Mutation Detection System

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

Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

FDA classification
FDA Class 2 ·Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes

Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control

FDA classification
FDA Class 2 ·Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control

Infusion Pump, Drug Specific, Pharmacy-Filled

FDA classification
FDA Class 2 ·Infusion Pump, Drug Specific, Pharmacy-Filled

Digital Pathology Display

FDA classification
FDA Class 2 ·Digital Pathology Display

System, Suction, Lipoplasty

FDA classification
FDA Class 2 ·System, Suction, Lipoplasty

Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions

FDA classification
FDA Class 2 ·Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions

Immunohistochemistry Assay, Antibody, Met

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Met

Immunohistochemistry Assay, Antibody, Claudin 18

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Claudin 18

Immunohistochemistry Assay, Antibody, Folr1

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Folr1

System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations

FDA classification
FDA Class 2 ·System, Mass Spectrometry, Multiplex Genotyping, Hereditary Thrombophilia Related Mutations

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA classification
FDA Class 3 ·Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

Lynch Syndrome Test System

FDA classification
FDA Class 2 ·Lynch Syndrome Test System