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U.S. Department of Health and Human Services

Product Classification

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Device enzyme immunoassay, antiparietal cell antibody, antigen, control
Regulation Description Antiparietal antibody immunological test system.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeMLE
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5110
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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