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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, amino acids, free carnitines and acylcarnitines tandem mass spectrometry
Regulation Description Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.
Definition Amino acids, free carnitines and acylcarnitines test system is intended for the measurement and evaluation of amino acid, free carnitine and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of the amino acids, free carnitines and acylcarnitines and their relationship with each other is intended to provide analyte concentration profiles that should aid in identifying elevated levels of these metabolites for screening newborns for one or more of several metabolic disorders.
Product CodeNQL
Regulation Number 862.1055
Device Class 2

MDR Year MDR Reports MDR Events
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Device Problem Information 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1 1

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