NTW

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class II (moderate risk)

Regulation

21 CFR 866.4070

Medical specialty

Immunology

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

Adverse events (MAUDE)

2018: 44 · 2019: 21 · 2023: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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