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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State Comprised of antigen coated microtiter plate, enzyme conjugate, substrate, controls
Technical Method Uses enzyme-linked, immunosorbent assay (ELISA) to identify the presence of anti-OMP antibodies.
Target Area human serum
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeOKM
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5785
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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