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

 EMAIL INQUIRY to  2 suppliers  
PerkinElmer, Inc.(LAS) | Address: 549 Albany Street, Boston, Massachusetts 02118-2512, USA USA
las.perkinelmer.com | Send Inquiry | Phone: +1-(203)-925-4602
Employee Count: ~9100
Products: Insulin, Insulin Growth Factor 1 Testing kit, Insulin Growth Factor and Binding Proteins III, Insulin Radioimmunoassay, Human Insulin ELISA Kit, Sensitive Rat Insulin RIA Kit, ...
PerkinElmer, Inc., manufactures and provides services for drug discovery, genetic screening and chemical analysis instrumentation, reagents and services for scientific research and clinical applicatio more...
 
Millenium Laboratories Of California | Address: 16981 Via Tazon Ste F, San Diego, California 92127, USA USA
www.milleniumlaboratories.com | Phone: +1-(877)-451-3534
Products: Digoxin, Therapeutic Drug Monitoring Reagents, Barbiturate Enzyme Immunoassay Test (FDA Code: DIS), Benzodiazepine Enzyme Immunoassay Test (FDA Code: JXM), Cocaine and Cocaine Metabolites Enzyme Immunoassay Test (FDA Code: DIO), Alcohol Containing Fixative (FDA Code: LDZ), Free Carnitines And Acylcarnitines Tandem Mass Spectrometry Amino Acids Test System (FDA Code: NQL), ...
Millennium Laboratories Of California deals with therapeutic drug monitoring devices. We offer urine tests for a range of drugs taken by patients for pain relief. We use mass spectrometry to identify more...
 EMAIL INQUIRY to  2 Free Carnitines And Acylcarnitines Tandem Mass Spectrometry Amino Acids Test System suppliers  
FDA Code / Regulation: NQL / 862.1055

A newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry is a device that consists of stable isotope internal standards, control materials, extraction solutions, flow solvents, instrumentation, software packages, and other reagents and materials. The device is intended for the measurement and evaluation of amino acids, free carnitine, and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of amino acids, free carnitine, and acylcarnitines and their relationship with each other provides analyte concentration profiles that may aid in screening newborns for one or more inborn errors of amino acid, free carnitine, and acyl-carnitine metabolism.

Classification. Class II (special controls). The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry." See 862.1(d) for the availability of this guidance document.

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