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

NQL · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1055

Classification

FDA Product Code
NQL
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 862.1055
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

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.

Market data

Cleared 510(k) submissions
5
Registered establishments
1

Source

Authoritative
FDA Device Classification database
Machine
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