36 results
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59ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: FDA Class 2
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ARCHITECT ROMA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ARCHITECT CA 15-3 ASSAY
FDA 510(k)
FDA Class 2
·Immunology
Lumipulse G Progesterone-N Calibrators
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Lumipulse G LH Calibrators
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Lumipulse G E2-III Calibrators
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS CA 19-9
FDA 510(k)
FDA Class 2
·Immunology
ARCHITECT TACROLIMUS: MODEL 1L77
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01,
FDA 510(k)
FDA Class 2
·Immunology
LUMIPULSE G1200 System, LUMIPULSE G CA 125II Immunoreaction Cartridges, LUMIPULSE G CA 125II Calibrators
FDA 510(k)
FDA Class 2
·Immunology
FUJIREBIO DIAGNOSTICS CA 19-9 RIA
FDA 510(k)
FDA Class 2
·Immunology
Lumipulse G TP-N Immunoreaction Cartridge Set
FDA 510(k)
FDA Class 2
·Microbiology
Lumipulse G CA15-3
FDA 510(k)
FDA Class 2
·Immunology
Lumipulse G CA19-9-N
FDA 510(k)
FDA Class 2
·Immunology
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
FDA 510(k)
FDA Class 2
·Immunology
AXSYM CORTISOL ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CYFRA 21-1 EIA MODEL 211-10
FDA 510(k)
FDA Class 2
·Immunology
Lumipulse G BRAHMS PCT Immunoreaction Cartridges, Lumipulse G BRAHMS PCT Calibrators set
FDA 510(k)
FDA Class 2
·Microbiology
Lumipulse G ß-Amyloid Ratio (1-42/1-40)
FDA 510(k)
FDA Class 2
·Immunology
ARCHITECT BNP ASSAY, MODEL 8K28
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARCHITECT CYCLOSPORINE
FDA 510(k)
FDA Class 2
·Clinical Chemistry