Device typeMetabolic profile clinical chemistry analyser IVD: A portable, electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters (e.g., pO2, pCO2), electrolytes [e.g., Sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes in addition haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)].
FDA categoryACID, LACTIC, ENZYMATIC METHOD, ASSAY, CARBOXYHEMOGLOBIN, ASSAY, FETAL HEMOGLOBIN, BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM, CALIBRATOR, MULTI-ANALYTE MIXTURE, ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH, ELECTRODE, ION SPECIFIC, CALCIUM, ELECTRODE, ION SPECIFIC, POTASSIUM, ELECTRODE, ION SPECIFIC, SODIUM, ELECTRODE, ION-SPECIFIC, CHLORIDE, GLUCOSE OXIDASE, GLUCOSE, Multi-analyte controls, all kinds (assayed), SYSTEM, HEMOGLOBIN, AUTOMATED
Device ID05700693930909
Catalog number393-090
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information