Product code
NTW: System, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test
FDA product code · Class II · Pathology
Key facts
| Product code | NTW |
|---|---|
| Device | System, blood collection, rna stabilization, rna purification, rt-pcr molecular diagnostic test |
| Device class | Class II |
| Regulation number | 866.4070 |
| Review panel | Pathology |
| Medical specialty | Immunology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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 |
At a glance
- 1–9 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database