987 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E601 IMMUNOSSAY ANALYZER
Hepatitis A Test (Antibody And Igm Antibody)
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR HAV IGM READY PACK REAGENTS, ADVIA CENTAUR HAV IGM QUALITY CONTROL MATERIALS
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ABBOTT REALTIME HCV, ABBOTT REALTIME HCV AMPLIFICATION REAGENT KIT, ABBOTT REALTIME HVC CONTROL KIT, ABBOTT REALTIME HCV
Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
FDA classification
FDA Class 2
·Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·HOME ACCESS HEPATITIS C CHECK
Suture, Surgical, Absorbable, Polydioxanone
FDA Pre-Market Approval
FDA Class 2
·PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HCV IMMUNOASSAY
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HCV IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV FOR USE ON COBAS E411 IMMUNOSSAY ANALYZER
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
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR HCV ON CENTAUR CP
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)
Glucose Oxidase, Glucose
FDA Pre-Market Approval
FDA Class 2
·GLUCOWATCH 2 BIOGRAPHER
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·ARTUS CMV RGQ MDX KIT
Glucose Oxidase, Glucose
FDA Pre-Market Approval
FDA Class 2
·GLUCOWATCH G2 AUTOMATIC GLUCOSE BIOGRAPHER
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·COBAS AMPLIPREP/COBAS TAQMAN CMV TEST
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK AND CALIBRATOR
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·COBAS AMPLIPREP/COBAS TAQMAN HCV TEST
System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
FDA Pre-Market Approval
FDA Class 2
·GEN-PROBE(R) AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST (MTD TEST)