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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device antibodies, outer-membrane proteins
Regulation Description Anti-Saccharomyces cerevisiae (S. cerevisiae) antibody (ASCA) test systems.
Definition For the detection of anti-outer membrane protein (anti-OMP) antibodies in human serum. To aid in the diagnosis of Crohn's Disease.
Product CodeOKM
Regulation Number 866.5785
Device Class 2

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