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New Search Back To Search Results 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 Code MQM Submission Type 510(k) Regulation Number 862.1113 Device Class 1 GMP Exempt? No Third Party Review Eligible for Accredited Persons Program Accredited Persons british standards institution center for measurement standards of industrial cheiroon bv citech intertek testing services regulatory technology services, llc tuv rheinland of north america, inc. tuv sud america inc. underwriters laboratories, inc.