8,389 results
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41ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Hepatitis A Test (Antibody And Igm Antibody)
FDA Pre-Market Approval
FDA Class 2
·DEVICE: ABBOTT AXSYM HAVAB-M 2.0
Hepatitis A Test (Antibody And Igm Antibody)
FDA Pre-Market Approval
FDA Class 2
·HA-IGMK AND ETI-HA-IGMK
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·COBAS® AmpliPrep/COBAS® TaqMan® CMV Test
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·Alinity m CMV
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR HCV
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test
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
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HCV II IMMUNOASSAY
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·Alinity i Anti-HCV Reagent Kit, Alinity i Anti-HCV Calibrator, Alinity i Anti-HCV Controls
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·COBAS AMPLICOR HCV TEST V2.0,COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
FDA Pre-Market Approval
FDA Class 2
·SENSITITRE
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
FDA Pre-Market Approval
FDA Class 2
·AUTOBAC MIC TEST SYSTEM
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ORAQUICK RAPID HCV ANTIBODY
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·COBAS® TaqMan® HCV Test, v2.0, for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test, v2.0
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
FDA Pre-Market Approval
FDA Class 2
·COBAS BACT
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 AND COBAS TAQMAN HCV TEST FOR USE WITH THE HIGH PURE SYSTEM
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·VITROS ANTI-HCV ASSAY
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ORAQUICK HCV RAPID ANTIBODY 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)
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
FDA Pre-Market Approval
FDA Class 2
·MIC TEST PANELS