814 results
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21ms
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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® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ADVIA CENTAUR HCV READYPACK REAGENNTS/QUALITY CONTROL MATERIALS
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK
Candida Spp., Direct Antigen, Id
FDA classification
FDA Class 2
·Candida Spp., Direct Antigen, Id
Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
FDA classification
FDA Class 2
·Software Device To Aid In The Prediction Or Diagnosis Of Sepsis
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·ARTUS CMV RGQ MDX KIT
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·BAYER VERSANT (TM) HCV RNA 3.0 ASSAY (BDNA)
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, 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
Antigen, Cf And / Or Id, Coccidioides Immitis
FDA classification
FDA Class 2
·Antigen, Cf And / Or Id, Coccidioides Immitis
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)
Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer
FDA classification
FDA Class 2
·Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HCV II TEST SYSTEM
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
FDA Pre-Market Approval
FDA Class 2
·ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHEK
Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
FDA classification
FDA Class 2
·Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Bone Sonometer
FDA Pre-Market Approval
FDA Class 2
·OMNISENSE 7000S ULTRASOUND BONE SONOMETER
Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HCV II IMMUNOASSAY
Cytomegalovirus (Cmv) Dna Quantitative Assay
FDA Pre-Market Approval
FDA Class 2
·Alinity m CMV
Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids
FDA classification
FDA Class 2
·Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids