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
| Device Type ID | 4919 |
| Device Name | System, Blood Collection, Rna Stabilization, Rna Purification, Rt-pcr Molecular Diagnostic Test |
| Regulation Description | RNA Preanalytical Systems. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.4070 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NTW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4919 |
| Device | System, Blood Collection, Rna Stabilization, Rna Purification, Rt-pcr Molecular Diagnostic Test |
| Product Code | NTW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | RNA Preanalytical Systems. |
| CFR Regulation Number | 866.4070 [🔎] |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 27 |
Leak / Splash | 6 |
Short Fill | 5 |
Incorrect Or Inadequate Test Results | 5 |
Device Markings / Labelling Problem | 4 |
Volume Accuracy Problem | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Material Deformation | 1 |
| Total Device Problems | 52 |