System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test
The RNA Blood Collection, Stabilization, Purification, and RT-PCR Molecular Diagnostic System is a complete system for collection, storage, and transport of whole blood with intracellular RNA stabilization, followed by isolation and purification of host RNA for use in RT-PCR-based molecular diagnostic testing. This integrated approach enables reliable gene expression analysis from clinical blood samples. It is an FDA Class 2 device regulated under 21 CFR 866.4070 in the Immunology specialty, reviewed by the Pathology panel, with product code NTW, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.
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Basic Information
- Product Code
- NTW
- Device Class
- FDA class 2
- Regulation Number
- 866.4070
- Medical Specialty
- Immunology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.