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U.S. Department of Health and Human Services

Product Classification

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Device system, test, urinary methylmalonic acid
Regulation Description Methylmalonic acid (nonquantitative) test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeLPT
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type Enforcement Discretion
Regulation Number 862.1509
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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