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.

Leading manufacturers include Perkinelmer, Inc., Perkinelmer Life Sciences, Inc. and Wallac Oy, Subsidiary of Perkinelmer, Inc..

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
1–5 of 5
Cleared Feb 07, 2020
NeoBase 2 Non-derivatized MSMS Kit
K193103
Perkinelmer, Inc.
Chemistry · 91d
Cleared Sep 04, 2018
NeoBase 2 Non-derivatized MSMS Kit
K173568
Wallac Oy, Subsidiary of Perkinelmer, Inc.
Chemistry · 288d
Cleared Aug 23, 2010
NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U
K093916
Perkinelmer, Inc.
Chemistry · 244d
Cleared Jul 09, 2009
NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040
K083130
Perkinelmer, Inc.
Chemistry · 259d
Not Cleared Aug 24, 2004
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970
DEN040002
Perkinelmer Life Sciences, Inc.
Chemistry · 53d

About Product Code NQL - Regulatory Context