Device typeMultiple lipid analyte IVD, reagent: A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple lipid analytes [e.g., total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL)] to generate a lipid profile of a clinical specimen. Some types may also detect additional analytes (e.g., glucose, ketones, uric acid).
FDA categoryColorimetric Method, Triglycerides, Enzymatic Esterase--Oxidase, Cholesterol, Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Device ID00893038002913
Catalog number97989
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information