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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device 21-hydroxylase antibody (21-ohab)
Regulation Description Multiple autoantibodies immunological test system.
Definition 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.
Product CodePCG
Regulation Number 866.5660
Device Class 2