DeviceClearance

Product code NTW— Immunology

MODIFICATION TO PAXGENE BLOOD RNA SYSTEM

Classification name
System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
Device class
Class 2
Regulation
21 CFR 866.4070
Advisory panel
Immunology
Total cleared
2
First cleared
Most recent

FDA classification 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”

— U.S. Food and Drug Administration, device classification record for product code NTW under 21 CFR 866.4070, via openFDA

Market context for product code NTW

FDA has cleared 2 devices under product code NTW between 2005 and 2009, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NTW

Recent clearances under product code NTW

Data sourced from openFDA. This site is unofficial and independent of the FDA.