Device typeIntrinsic factor/parietal cell antibody 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 intrinsic factor and/or parietal cells in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of conditions associated with deficiencies in intrinsic factor and/or parietal cell function/production such as autoimmune gastric disorders (e.g., pernicious anaemia, chronic atrophic gastritis), funicular myelosis, and various autoimmune endocrinopathies.
FDA categoryEnzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Device ID08426950448310
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information