139 results
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113ms
·
Sources: EU EUDAMED, US FDA
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
FUJIREBIO DIAGNOSTICS VITAMIN D CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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
FDI GLUCOSE CONTROL SOLUTIONS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA
FDA 510(k)
FDA Class 1
·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
Lumipulse G Prolactin
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ROMA (HE4 EIA + ARCHITECT CA 125 II)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HE4 EIA, MODEL: 404-10 US
FDA 510(k)
FDA Class 2
·Immunology
FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ARCHITECT CA 19-9XR ASSAY
FDA 510(k)
FDA Class 2
·Immunology