NQL
5 FDA 510(k) clearances · Product code
244 daysmedian time to decision
288 days90th percentile
5clearances measured
FDA profile
- Official device name
- System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1055
- Medical specialty
- Clinical Chemistry
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NeoBase 2 Non-derivatized MSMS Kit (K193103) | Perkinelmer, Inc. | 2020-02-07 |
| NeoBase 2 Non-derivatized MSMS Kit (K173568) | Wallac Oy, Subsidiary of Perkinelmer, Inc. | 2018-09-04 |
| NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U (K093916) | Perkinelmer, Inc. | 2010-08-23 |
| NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040 (K083130) | Perkinelmer, Inc. | 2009-07-09 |
| NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 (DEN040002) | Perkinelmer Life Sciences, Inc. | 2004-08-24 |
Track NQL automatically
Every clearance here is in the API, with alerts when new ones post.