Device typeMultiple clinical chemistry analyser IVD, point-of-care: A portable, electrically-powered instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technology(ies) [e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence]. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.
FDA categoryGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
Device ID00819704020616
Catalog number100-000031
MRI safetyLabeling does not contain MRI Safety Information