Device typeLDL (low density lipoprotein) antibody (anti-LDL) IVD, kit, enzyme immunoassay (EIA): A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to low density lipoprotein (anti-LDL) in a clinical specimen, using an enzyme immunoassay (EIA) method.
FDA categoryCALIBRATOR, SECONDARY, LIPOPROTEIN, LOW-DENSITY, ANTIGEN, ANTISERUM, CONTROL, SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)
Device ID00817302020151
Catalog numberCC204-100-D
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information
SizeKit contains 2 reagent cartridges 1 reagent package insert and 1 user defined parameters package insert
Total Volume4 Milliliter
Total Volume15 Milliliter