NTW · Class II · 21 CFR 866.4070

FDA Product Code NTW: System, Blood Collection, Rna Stabilization, Rna Purification, Rt-pcr Molecular Diagnostic Test

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

Leading manufacturers include Preanalytix GmbH.

2
Total
1
Cleared
119d
Avg days
2005
Since

FDA 510(k) Cleared System, Blood Collection, Rna Stabilization, Rna Purification, Rt-pcr Molecular Diagnostic Test Devices (Product Code NTW)

2 devices
1–2 of 2
Cleared Feb 04, 2009
MODIFICATION TO PAXGENE BLOOD RNA SYSTEM
K082150
Preanalytix GmbH
Pathology · 189d
Not Cleared Apr 18, 2005
PAXGENE BLOOD RNA SYSTEM
DEN050003
Preanalytix GmbH
Pathology · 49d

About Product Code NTW - Regulatory Context