1,019 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 3
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Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS AmpliPrep/ COBAS TaqMan HBV Test, v 2.0
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Roche Cobas AmpliPrep/Cobas TaqMan HBV Test, v2.0
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·Roche 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
·AXSYM CORE-M 2.0
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ADVIA CENTAUR ANTI-HBS2 MASTER CURVE MATERIALS
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS® AmpliPrep/COBAS® TaqMan® HBV Test
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IGM IMMUNOASSAY & ELECSYS PREICONTROL ANTI-HBC IGM FOR USE ON THE MODULAR ANAYTICS E170 IMMUNOASSAY ANA
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBE REAGENT PACK/ANTI-HBE CALIBRATOR/ANTI HBE CONTROLS
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·ARCHITECT AUSAB, ARCHITECT I1000 SYSTEM
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS® TaqMan® HBV Test for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODEL PA48A-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS® AmpliPrep, COBAS® TaqMan® HBV Test, v2.0
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·MODELS GL65C-OUV ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS TaqMan HBV Test, For Use With High Pure System
Hepatitis Viral B Dna Detection
FDA Pre-Market Approval
FDA Class 3
·COBAS TAQMAN HBV FOR USE WITH THE HIGH PURE SYSTEM
Hepatitis Viral B Dna Detection
FDA classification
FDA Class 3
·Hepatitis Viral B Dna Detection
Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)
FDA Pre-Market Approval
FDA Class 3
·LIAISON® XL MUREX HBsAg Qual, LIAISON® MUREX Control HBsAg, and LIAISON® XL MUREX HBsAg Confirmatory Test