inforMED
NTWClass II

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

Immunology · 21 CFR 866.4070

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

MDR events148All time
Recalls1All time
Registered firms6Currently listed
510(k) clearances2All time

Recent MDR events

148 adverse event reports on file

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Event type breakdown

Malfunction146
Injury1
Other1

Most-reported manufacturers

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Becton, Dickinson And Company (bd)142Preanalytix Gmbh2Unspecified1Becton Dickinson1Becton Dickinson & Co (franklin Lakes)1Qiagen Gmbh1

Recalls

1 recall events for this product code

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Registered firms

6 firms currently registered for this product code

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510(k) clearances

2 clearances for this product code

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