inforMED
PCGClass II

21-hydroxylase Antibody (21-ohab)

Immunology · 21 CFR 866.5660

For semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.

MDR events0All time
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Registered firms6Currently listed
510(k) clearances2All time

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