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U.S. Department of Health and Human Services

Product Classification

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Device bilirubin (total and unbound) in the neonate test system
Regulation Description Bilirubin (total and unbound) in the neonate test system.
Regulation Medical Specialty Clinical Chemistry
Review Panel Clinical Chemistry
Product CodeMQM
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 862.1113
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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