27 results · 41ms · Sources: EU EUDAMED, US FDA

System, Multipurpose For In Vitro Coagulation Studies

FDA classification
FDA Class 2 ·System, Multipurpose For In Vitro Coagulation Studies

Assay For Detection Of Proteases In Chronic Wounds

FDA classification
FDA Class 2 ·Assay For Detection Of Proteases In Chronic Wounds

Cell Enzymes (Erythrocytic And Leukocytic)

FDA classification
FDA Class 2 ·Cell Enzymes (Erythrocytic And Leukocytic)

Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

FDA classification
FDA Class 2 ·Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA classification
FDA Class 3 ·System, Test, Tumor Marker, For Detection Of Bladder Cancer

System, Test, Tumor Marker, Monitoring, Bladder

FDA classification
FDA Class 2 ·System, Test, Tumor Marker, Monitoring, Bladder

Kit, Direct Antigen, Positive Control

FDA classification
FDA Class 1 ·Kit, Direct Antigen, Positive Control

System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

FDA classification
FDA Class 2 ·System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies

Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

FDA classification
FDA Class 2 ·Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

Plasmodium Spp. Detection Reagents

FDA classification
FDA Class 2 ·Plasmodium Spp. Detection Reagents

Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test

FDA classification
FDA Class 2 ·Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test

Multi-Analyte Respiratory Virus Antigen Detection Test

FDA classification
FDA Class 2 ·Multi-Analyte Respiratory Virus Antigen Detection Test

Human Metapneumovirus (Hmpv) Rna Assay System

FDA classification
FDA Class 2 ·Human Metapneumovirus (Hmpv) Rna Assay System

Legionella, Spp., Elisa

FDA classification
FDA Class 2 ·Legionella, Spp., Elisa

Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

FDA classification
FDA Class 2 ·Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Influenza A And Influenza B Multiplex Nucleic Acid Assay

FDA classification
FDA Class 2 ·Influenza A And Influenza B Multiplex Nucleic Acid Assay

Antisera, All Groups, Streptococcus Spp.

FDA classification
FDA Class 1 ·Antisera, All Groups, Streptococcus Spp.

Respiratory Virus Panel Nucleic Acid Assay System

FDA classification
FDA Class 2 ·Respiratory Virus Panel Nucleic Acid Assay System

Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

FDA classification
FDA Class 1 ·Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

Devices Detecting Influenza A, B, And C Virus Antigens

FDA classification
FDA Class 2 ·Devices Detecting Influenza A, B, And C Virus Antigens