2,134 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·DIGENE HYBRID CAPTURE 2 (HC2) HIGH-RISK HPV DNA TEST
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·IMMULITE/IMMULITE 1000 AND IMMULITE 2000 ANTI-HBC
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·Elecsys HBsAg II
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·cobas HBV
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Alinity m HBV assay
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·digene HC2 High Risk HPV DNA Test
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS AMPLIPREP/COBAS TAQMAN HBV TEST, V2.0
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBSAG/CONFIRMATORY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON® XL MUREX Anti-HBe assay and Control
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Cervista HPV HR Assay
Hepatitis Delta Serological Reagents
FDA Pre-Market Approval
FDA Class 3
·ABBOTT ANTI-DELTA EIA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSCYS HBSAG IMMUNOASSAY, ELECSYS PRECICONTROL HBSAG, ELECSYS HBSAG CONFIRMATORY TEST
Kit, Dna Detection, Human Papillomavirus
FDA Pre-Market Approval
FDA Class 3
·Alinity m HR HPV
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT HBSAG QUALITATIVE/CONFIMATORY
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT CORE-M
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK AND CALIBRATOR
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS HBSAG CONFIRMATORY TEST
Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test
FDA Pre-Market Approval
FDA Class 3
·T-SPOT. TB Test
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HBC FOR USE ON THE ELECSYS 2010 IMMUNOASSAY ANALYZER
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBS CALCHECK