510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NTWClass II

System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test

21 CFR 866.4070 / Immunology
FDA source (opens on fda.gov)

NTW is the FDA product code for System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test, a class II device type, regulated under 21 CFR 866.4070. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
NTW
Device name
System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
FDA 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
Regulation
21 CFR 866.4070
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
1

Clearances, product code NTW

By decision year
2 clearances under product code NTW with a decision year between 2005 and 2009, 2005 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NTW by decision year
YearClearances
20051
20091

Applicants with the most clearances

Product code NTW
Applicants holding the most 510(k) clearances under product code NTW
ApplicantClearances
Preanalytix GmbH2

Companies listing this code with FDA

Companies whose registered establishments list this code