Device typeFluorescent immunoassay analyser IVD, laboratory: An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a clinical specimen. The instrument detects fluorescent markers that result from an immunological reaction between the reagents and the specimen, and typically includes an autosampler, reagent dispenser, light source, filter or monochromator, a fluorescent detection system (fluorometer or spectrofluorometer), data processing and/or data display software.
FDA categoryANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)
Device ID07333066020921
Catalog number12-4100-01
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information