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U.S. Department of Health and Human Services

Product Classification

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Device system, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test
Regulation Description RNA Preanalytical Systems.
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 Medical Specialty Immunology
Review Panel Immunology
Product CodeNTW
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.4070
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification Systems for RT-PCR used in Molecular Diagnostic Testing)
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible