NTW — System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test Class II

FDA Device Classification

Classification Details

Product Code
NTW
Device Class
Class II
Regulation Number
866.4070
Submission Type
Review Panel
PA
Medical Specialty
Immunology
Implant
No

Definition

System for collection, storage, and transport of whole blood and stabilization of intracellular rna with subsequent isolation and purification of host rna for rt-pcr used in molecular diagnostic testing

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K082150preanalytixMODIFICATION TO PAXGENE BLOOD RNA SYSTEMFebruary 4, 2009
DEN050003preanalytixPAXGENE BLOOD RNA SYSTEMApril 18, 2005