NQL · Class II · 21 CFR 862.1055

FDA Product Code NQL: System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

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.

5
Total
4
Cleared
187d
Avg days
2004
Since

FDA 510(k) Cleared System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry Devices (Product Code NQL)

5 devices
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About Product Code NQL - Regulatory Context