987 results · 23ms · Sources: EU EUDAMED, US FDA

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)