139 results · 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 B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S 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