Cardiac Allograft Gene Expression Profiling Test System Suppliers
EMAIL INQUIRY to 1 suppliers
XDx, Inc. | Address: 3260 Bayshore Boulevard, Brisbane, California 94005, USA 
www.xdx.com | Send Inquiry | Phone: +1-(415)-2872300
FDA Registration: 3005225997
Products: Molecular Diagnostic Services, General Purpose Reagent (FDA Code: LDT), Cardiac Allograft Gene Expression Profiling Test System (FDA Code: OJQ), ...
XDx, Inc. is a molecular diagnostics company. The molecular diagnostic assays based on gene expression patterns in blood cells provide clinically useful information. The gene expression patterns refle more...
www.xdx.com | Send Inquiry | Phone: +1-(415)-2872300
FDA Registration: 3005225997
Products: Molecular Diagnostic Services, General Purpose Reagent (FDA Code: LDT), Cardiac Allograft Gene Expression Profiling Test System (FDA Code: OJQ), ...
XDx, Inc. is a molecular diagnostics company. The molecular diagnostic assays based on gene expression patterns in blood cells provide clinically useful information. The gene expression patterns refle more...
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EMAIL INQUIRY to 1 Cardiac Allograft Gene Expression Profiling Test System suppliers
FDA Code / Regulation: OJQ / 862.1163
A cardiac allograft gene expression profiling test system is a device that measures the ribonucleic acid (RNA) expression level of multiple genes and combines this information to yield a signature (pattern, classifier, index, score) to aid in the identification of a low probability of acute cellular rejection (ACR) in heart transplant recipients with stable allograft function.
Classification. Class II (special controls). The special control is FDA's guidance document entitled "Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test Systems." See 862.1(d) for the availability of this guidance document.
