111 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·cobas CMV
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·cobas CMV Test
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ORAQUICK HCV RAPID ANTIBODY TEST
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·Cobas AmpliPrep and Cobas TaqMan CMV Test
Assay, Genotyping, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·VERSANT HCV Genotype 2.0 Assay (LiPA)
System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
FDA Pre-Market Approval
FDA Class 2
·GEN-PROBE ABPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST
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, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·Aptima HCV RNA Qualitative Assay
Full Field Digital, System, X-Ray, Mammographic
FDA Pre-Market Approval
FDA Class 2
·FULL FIELD DIGITAL MAMMOGRAPHY
UFI GEL HARD
FDA 510(k)
FDA Class 2
·Dental
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·artus CMV RGQ MDx Kit and artus CMV QS-RGO MDx Kit
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·RAPTORAIL PTCA DILATATION CATHETER (RX)
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ADVIA Centaur HCV ReadyPack Reagents, Atellica IM Hepatitis C (aHCV), Atellica IM Hepatitis C Quality Control(aHCV QC)
Full Field Digital, System, X-Ray, Mammographic
FDA Pre-Market Approval
FDA Class 2
·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK & VITRO IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CALIBRATOR
Glucose Oxidase, Glucose
FDA Pre-Market Approval
FDA Class 2
·GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
Assay, Genotyping, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·Abbott RealTime HCV Genotype II Assay
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 Assay
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ABBOTT REAL TIME HBV CALIBRATOR KIT
System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex
FDA Pre-Market Approval
FDA Class 2
·ROCHE AMPLICOR MYCOBACTERIUM TUBERCULOSIS TEST