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

NTW · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.4070

Classification

FDA Product Code: NTW
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.4070
Review panel: PA
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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

Market data

Cleared 510(k) submissions: 2
Registered establishments: 5

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown