35 results
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9ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
FDA 510(k)
FDA Class 2
·Hematology
AQUANET, MODEL EC 2000
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Physical Medicine
Qualitative And Quantitative Hepatitis B Virus Antibody Assays
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HBC IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HBC
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBc II / Elecsys Anti-HBc IgM
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBc II
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HBC
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HBC IMMUNOASSAY ON MODULAR ANALYTICS E170
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBc II
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBc II
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBc II
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBc II
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HBC ON MODULAR ANALYTICS E170
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBc II
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HBC IMMUNOASSAY
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HBC IMMUNOASSAY ON MODULAR ANALYSTICS E170
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·ELECSYS ANTI-HBC TEST SYSTEM
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBc II
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
FDA Pre-Market Approval
FDA Class 2
·Elecsys Anti-HBc II, PreciControl Anti-HBc