Device typeHaematological cell analyser IVD: An electrically-powered automated or semi-automated laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity, cytometry, and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. Some types may also include measurement of haemoglobin.
FDA categoryCOUNTER, CELL, AUTOMATED (PARTICLE COUNTER), Counter, differential cell
Device ID04987562402021
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information