741 results
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19ms
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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
·IMX HAVAB
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ARCHITECT ANTI-HCV
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·Dimension Vista TPSA Flex reagent cartridge (K6451)
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·Alinity m CMV Assay
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·Dimension TPSA Flex Reagent Cartridge
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·COBAS AMPLIPREP/COBAS TAQMAN CMV TEST
Full Field Digital, System, X-Ray, Mammographic
FDA Pre-Market Approval
FDA Class 2
·SENOGRAPHE DS & 2000D FFDM SYSTEM
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/COMBAS TAQMAN HCV TEST V2.0
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ARCHITECT ANTI-HCV ASSAY; ARCHITECT ANTI-HCV CALIBRATOR; ARCHITECT ANTI-HCV CONTROL
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·VERSANT HCV RNA 3.0 ASSAY (BDNA)
Hepatitis A Test (Antibody And Igm Antibody)
FDA Pre-Market Approval
FDA Class 2
·HAVAB-M (R) EIA
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·Dimension TPSA Flex reagent cartridge (RF451)
Analyzer, Medical Image
FDA Pre-Market Approval
FDA Class 2
·IMAGECHECKER M1000 PROCESSOR WITH V1.3 RELEASE
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·IMMULITE PSA CATALOG # LKPS1,5)
Catheter, Electrode Recording, Or Probe, Electrode Recording
FDA Pre-Market Approval
FDA Class 2
·NaviStar RMT Catheter, NaviStar Catheter, EZ Steer NAV Catheter,
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
FDA Pre-Market Approval
FDA Class 2
·MICROSCAN RAPID FLUOROGENIC PANELS
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
System, Test, Carcinoembryonic Antigen
FDA Pre-Market Approval
FDA Class 2
·OPUS(R) CEA TEST SYSTEM
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·Atellica IM Hepatitis C (aHCV) Assay
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 THE MODULAR ANALYTICS E170 IMMUNOASSAY ANALYZER