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System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

FDA product code NQL · 4 cleared devices

Class 2 Clinical Chemistry
Regulation
21 CFR 862.1055
Review panel
CH
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2009-07-09 – 2020-02-07

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.

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