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510(k) DEN050003

PAXGENE BLOOD RNA SYSTEM by Preanalytix GmbH — Product Code NTW

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
April 18, 2005
Date Received
February 28, 2005
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
Device Class
Class II
Regulation Number
866.4070
Review Panel
PA
Submission Type

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

Other clearances by Preanalytix GmbH

  • K231469 — PAXgene® Blood DNA Tube (June 21, 2023)
  • K142821 — PAXgene Blood DNA Tube (September 9, 2015)
  • K082150 — MODIFICATION TO PAXGENE BLOOD RNA SYSTEM (February 4, 2009)

Other clearances for product code NTW

  • K082150 — MODIFICATION TO PAXGENE BLOOD RNA SYSTEM (February 4, 2009)